Blood products, which did not meet the acceptable product specifications, were distributed.
Red Blood Cells Leukocytes Reduced Washed
Lifesouth Community Blood Centers - Montgomery Region
Blood product, associated with a unit of platelets with an unacceptable pH, was distributed
Blood products, which was not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Blood products, associated with a unit of platelets with an unacceptable pH, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
Amerigel Hydrogel Wound Dressing   Wound management
Amerigel Post-op Surgical Kits   Wound management
Amerigel Daily Dressing Packets   Wound management
Amerigel Saturated Gauze Dressing   Wound management
Distributed to Puerto Rico, Florida, and New York.
Suture Removal Kit   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging.  Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Irrigation Tray With Bulb Syringe, Catalog number 900-020.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Universal Drainage Tray, Catalog number 900-032.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Closure Tray I, Catalog number 900-063.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Closure Tray II, Catalog number 900-064.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Tracheotomy Care Kit, Catalog number 900-110.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Suction Catheter Kit, Catalog number 900-277.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Uretheral Catheter Tray, Catalog number 900-278.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Surgeon Reinforced Gown XL, Catalog number 900-521.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Management Tray Ill, Catalog number 900-540.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Utility Drape End Product, Catalog number 900-582.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Incision & Drainage Tray, Catalog number 900-774.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Skin Staple Removal, Catalog number 900-782.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Management Tray, Catalog number 900-1154.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Management Tray II, Catalog number 900-1198.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Surgical Non Reinforced XL, Catalog number 900-1579.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Management Tray Ryder Memorial, Catalog number 900-1456.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Leggings W/7'' Cuff, Catalog number 900-1574.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Minor Laceration Tray, Catalog number 900-1765.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Wound Management Tray, Catalog number 900-1903.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
US Distribution to states of Florida and New York including Puerto Rico.
Gown Surg Fully Impervious Large, Catalog number 900-2564.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Surgical Non Reinforced XXL, Catalog number 900-2566.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Fabric Reinforced XXL, Catalog number 900-2567.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Surgical Fabric Reinforced XL, Catalog number 900-2568.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Surgical Fabic Reinforced Large, Catalog number 900-2569.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Angiodrape Pack, Catalog number 900-002.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
O.B. Pack, Catalog number 900-012.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-028.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Major Laparotomy Pack, Catalog number 900-036.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cysto Tur Pack, Catalog number 900-080.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
OB Pack, Catalog number 900-1030.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, Catalog number 900-1042.    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Chole Pack, Catalog number 900-1059.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Peri Gyn Pack, Catalog number 900-1061.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, Catalog number 900-1062.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Peri Gyn Pack, Catalog number 900-1091.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Foley Catheter Kit, Catalog number 900-1127.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Foley Catheter Kit, Catalog number 900-1139    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Neuro Pack, Catalog number 900-1146.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-1176.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy OB GYN Pack, Catalog number 900-1192.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Open Heart Tray, Catalog number 900-1196C    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laminectomy Pack, Catalog number 900-1202.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Premium Cesarean Pack, Catalog number 900-1294    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Premium Laparotomy Pack, Catalog number 900-1296.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Premium OB Pack, Catalog number 900-1297.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Neuro Spine Pack, Catalog number 900-1300    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Pediatric Lap Pack, Catalog number 900-1383    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Open Heart Tray, Catalog number 900-1393.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Plastic Surgery Pack, Catalog number 900-1402.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Umbilical Vessel Catheter Kit, Catalog number 900-1408.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cirugia Cardiovascular Case Cart, Catalog number 900-1415A.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reyito Urological Pack, Catalog number 900-1460.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
D&C Laparoscopy Pack, Catalog number 900-1476.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
ENT Pack, Catalog number 900-1482.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Angiography Pack, Catalog number 900-1488.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, Catalog number 900-149.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
D&C Laparoscopy Pack, Catalog number 900-1496.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cirugia Cardiovascular Case Cart, Catalog number 900-1500.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Urology Pack, Catalog number 900-1521.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Dressing Change, Catalog number 900-1538.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Universal Pack, Catalog number 900-1587.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Retina Pack, Catalog number 900-1611.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Femoral Pack, Catalog number 900-164.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Labor & Delivery Pack, Catalog number 900-168.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Chole Pack, Catalog number 900-1688.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog number 900-1689.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Open Heart Tray, Catalog number 900-170.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Peri Gyn Pack, Catalog number 900-1716.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
OB Pack, Catalog number 900-1717.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog number 900-1719.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Minor Laparotomy Pack, Catalog number 900-1735.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Urology Pack, Catalog number 900-1738.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Urology Pack, Catalog number 900-1742.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, Catalog number 900-176.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Ophtalmic Pack, Catalog number 900-1780.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Premium Pack, Catalog number 900-1803.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, Catalog number 900-1832.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Hip Orthopedia Pack, Catalog number 900-1835.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Ophtalmic Pack, Catalog number 900-1933.    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Universal Pack, Catalog number 900-1936.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Endovenous Custom Pack, Catalog number 900-1937.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Higado & Pancrea Pack, Catalog number 900-1966.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-1967.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Orthopedic tray, Catalog number 900-1985    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Chole Pack, Catalog number 900-2004.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Angiography Pack, Catalog number 900-2038.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Angiography Pack, catalog #900-210   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Knee Arthroscopy Pack, catalog #900-2123   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Femoral Pack Femoral Pack, catalog #900-2164   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Lithotomy Pack, catalog #900-2167   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Shoulder Arthroscopy Pack, catalog #900-2193   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Surgical Pack, catalog #900-2224   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Ear Pack, catalog #900-2234   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Neuro Pack, catalog #900-2256   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Colorectal Surgical Pack, catalog #900-2259A   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
General Line Full Body Drape, catalog #900-2262   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Vaginal Procedure Pack, catalog #900-2385   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Total Hysterectomy, catalog #900-2415   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Extremity Arm Pack, catalog #900-2438   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Basic Pack 1 (III), catalog #900-2471   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, catalog #900-2473   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cystoscopy Pack III, catalog #900-2482   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy and Pack (1)(2), catalog #900-2483   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack 1 (2 &#38; 3), catalog #900-2490   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Transverse Laparotomy Pack (8), catalog #900-2491   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack III (4), catalog #900-2492   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Urology Pack, catalog #900-2510   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Minor Pack, catalog #900-2511   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, catalog #900-2516   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
OB Pack, catalog #900-254   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Cool Impervious XLGE Breathable, catalog #900-2592   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, catalog #900-2609   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Hip &#38; Knee Replacement, catalog #900-2614   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Extremity PACK, catalog #900-2615   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Shoulder Pack, catalog #900-2616   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Open Heart Pack, catalog #900-2618   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Liposuction Pack, catalog #900-2656   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Tummy Tuck &#38; Liposuction Pack, catalog #900-2661   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Bandeja para Debridacion (Debridement Tray), Catalog #900-2702   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Shoulder Pack, catalog #900-2766   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Surgical Pack, catalog #900-281A   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, catalog #900-2829   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Orthopedic Pack, catalog #900-2830   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cysto Tur Pack, catalog #900-2899   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
ACDF Pack, catalog #900-2917   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Hair Restoration Pack, Catalog #900-2966   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Tummy Tuck Pack, Catalog #900-3026   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Liposuction Pack, Catalog #900-3028   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Breast Pack   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Face Lift, Catalog number 900-3083.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-3178.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Breat Pack-TPSC, Catalog number 900-3431.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Basic Pack W/Out Gown, Catalog number 900-345.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog number 900-403.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Major Lap Pack, Catalog number 900-404.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog number 900-410.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Chole Pack, Catalog number 900-414.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Labor & Delivery Pack,  Catalog number 900-419.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cysto Tur Pack, Catalog number 900-430    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Minor Laparotomy Pack, Catalog number 900-450.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-474.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-484    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Pack, Catalog number 900-486.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Basic Pack, Catalog number 900-547    Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Pery GYN Surgical Pack, Catalog number 900-548A.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparoscopy Gyn Pack, Catalog number 900-605.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Angiography Pack, Catalog number 900-610.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, Catalog number 900-620.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
O.R. Towels, Catalog number 900-629.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Fanfold Drape, Catalog number 900-633.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Pery Gyn Pack, Catalog number 900-635.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
O.B. Pack, Catalog number 900-645.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog # 900-660   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Surgical Pack, Catalog # 900-740A   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Carpal Tunnel Surgical Large Pack, Catalog # 900-742A   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Neuro Pack, Catalog # 900-752   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
General Minor Pack, Catalog # 900-787   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Femoral Angiography Pack, Catalog number 900-796.   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, Catalog # 900-848   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cesarean Pack, Catalog # 900-851   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Urology Pack, Catalog # 900-868   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthroscopy Pack, Catalog # 900-902   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Significant compromised sterility, not limited to potentially damaged packaging.  Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Curation Kit, Catalog # 900-913   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Plastic Surgery Pack, Catalog # 900-920   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
C-Section Surgical Pack, Catalog # 900-921A   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Cataract Pack, Catalog # 900-944   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Strabismus And Plastic Pack, Catalog # 900-946   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Arthoscopy Pack, Catalog # 900-982   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Laparotomy Pack, Catalog # 900-996   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Peri Gyn Pack, Catalog # 900-997   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
C-Section Pack, Catalog # 900-998   Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Blood product, collected from a donor who had been incarcerated, was distributed.
Inova Health Care Services, Inova Blood Donor Services
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, with a low platelet count, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Queso Seco Centroamericano (Cheese) in individually soft poly/plastic bags  labeled in part: Lacteos Santa Martha Queso Seco Centroamericano Dry White Cheese Net Wt 1LB (16oz)
Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd; FDA made an inspection, were the environmental samples  that came up positive also for Listeria monocytogenes, also the firm sent samples to a private lab that came positive for Listeria monocytogenes in various products.  The firm is voluntarily recalling all their Lacteos Santa Martha products manufactured that are within expiration date.
Queso Seco Olanchano (Olanchano Style Cheese) in individually soft poly/plastic bags  labeled in part: Lacteos Santa Martha Queso Seco Olanchano Dry Cheese Net Wt 1LB (16oz)
Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes.  Oasis Brands Inc.  is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date.
Queso Seco Hondureno (Honduran Style Dry Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Hondureno Dry Cheese Net Wt 12oz (340g)
Quesito Casero (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Quesito Casero Fresh Curd Net Wt 12oz. (340g)
My Queso (Latin Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha My Queso Latin Flavor Cheese Net Wt 1LB (16oz)
Queso Cuzcatlan (Salvadorean Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Cuzcatlan Salvadorean Flavor Cheese Net Wt 1LB (16oz)
Queso Para Freir (Cheese for Frying) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso para Freir Cheese for Frying  Net Wt 1LB (16oz)
Queso Fresco (Fresh Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Fresco Fresh Cheese Net Wt 12oz (340g)
Cuajada en Hoja (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd Net Wt 12oz (340g)
Crema Centroamericana (Centroamerican Style Soft Blend Dairy Spread) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Centroamericana Net Wt 1LB (16oz)
Mantequilla Hondurena (Honduran Style Butter Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Mantequilla Hondurena Honduran Style Cream Net WT 1 LB (16 oz)
Crema Nica (Nica Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Nica Grade A Cultured Cream  Net WT 1 LB (16 oz)
HonduCrema (Hunduran Olanchana Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha HonduCrema Crema Olanchana Olanchana Style Soft Blend Dairy Spread Net WT 1 LB (16 oz)
Crema Guatemalteca (Guatemaltecan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Guatemalteca Guatemalan Style Cream Net WT 1 LB (16 oz)
Crema GuateLinda (Guatemalan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema GuateLinda Guatemalan Style Cream Net WT 1 LB (16 oz)
Crema Cuzcatlan (Salvadorean Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Cuzcatlan Salvadorean Style Cream Net WT 1 LB (16 oz)
Amer.  National Red Cross-Greater Chesapeake & Potomac Reg.
Blood product, collected from a donor with an invalid result for body temperature, was distributed
Blood product, collected from a donor with an invalid result for body temperature, was distributed.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval
Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore.  BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.
Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411
Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411
Deep Raw Cashew Pieces Distributed by Chetak New York LLC Edison, NJ  08837 USA    7 oz. - UPC 011433133104 - 20 per case  14 oz. - UPC 011433133111 - 20 per case  28 oz. - UPC 011433133128 - 10 per case    packaged in a plastic bag; for dry storage
Deep Raw Cashew Pieces may be contaminated with Salmonella.
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Item Number FV129 Lot Number 4506244166  Serial Number A10150
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units.  The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag.  However, the expiration date on the outer box was correct.  No patient injuries were reported as a result of this issue.
Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombia, Czech Republic,Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Kenya, Korea, Kazakhstan, Malaysia, Netherlands, Norway, New Zealand, Philippines, Pakistan, Poland, Palestina, Portugal, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, Vietnam and South Africa.
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the &quot;Block Radiation&quot; key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This would result in no X-ray release and a delay in procedure.
US Distribution in states of: AZ, CO, IL, OR, and WA.
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer   The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
US Distribution including the states of NY, MO and NV.
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562   The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.
The product has been identified to contain an incorrect curette type.
Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop  material to help secure a nasal interface.    The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It  is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128;  Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J.   Used in anesthesiology.
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70.   Used in anesthesiology.
US Distribution including the states of and in only five locations in VA, NH, OH and TX.
GDC-10 360 SOFT 3mm x 6cm SR ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the  treating neurosurgical team to be    a) very high risk for management by traditional operative techniques, or b) inoperable
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
GDC-10 360 10mm x 30cm SR ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the  treating neurosurgical team to be    a) very high risk for management by traditional operative techniques, or b) inoperable
GDC-18 360 20mm x 33cm ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the  treating neurosurgical team to be    a) very high risk for management by traditional operative techniques, or b) inoperable
Target 360 Standard 12mm x 30cm;   Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  Target Detachable Coils are indicated for endovascular embolization of:  '' Intracranial aneurysms  '' Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae  '' Arterial and venous embolizations in the peripheral vasculature
US Distribution to the states of: VA, NH, OH and TX.
Gateway OTW 2.75mm x 9mm;   The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1;    intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Australia, Belgium, Hong Kong, Japan, Bosnia, France, Estonia, Germany, Greece, Hungary, Iceland, Israel, Iraq, Latvia, Saudi Arabia, Spain, UAE, Paraguay, Pakistan, Vietnam, and Kurdistan.
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
US Distribution to state of: TX, OK, LA, and AR.
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically.
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only,  Manufactured for Sandoz Inc., Princeton,  NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India,  NDC 0781-5938-92
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10  Pouch Label UPC (P10) *+M405P100C*  Intermediate Box Label UPC (P10) *+M405P103F*  Carton Label UPC (P10) *+M405P105H*    The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches).    There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case.    Intended to be used by pediatric males and females for the purpose of bladder drainage
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters.  Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO - Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. Because of this change, some ConMed's multifunction electrodes will not connect to these AEDs.  The HeartStart FRx AED unit requires the pads to be pre-connected, and will issue an alarm chirp to alert the user that the proper pads are not connected to the unit.  The HeartStart FR3 however, does not require pre-connection and the user will not discover the compatibility issue until the AED is to be used.  In this circumstance, the failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vinegar, Worcestershire Sauce, Onions and Spices, P.O. Box 22764, Hilton Head Island, SC 29925.
Expiration date of 08-31-2016 through 11-03-2016
Undeclared non-allergens, soy, wheat, anchovies.
Gourmet Warehouse, Island Jerk Marinade, 16 fl oz. (473 mL), Ingredient: Soy Sauce, Lemon Juice, Thyme, Allspice, Onion, Garlic, Cayenne Pepper, Salt, Savory Paprika, Spices, P.O. Box 22764, Hilton Head Island, SC 29925.
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Polyflux Revaclear Dialyzer, Model Number 110633.   The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
Polyflux Revaclear Max Dialyzer, Model Number 110634.   The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
PERMA-HAND'' Silk Suture [Siliconized black braided] Product Code - 10Q06 Lots and Expiration Dates- GPP528 JUL 2018 GPP908 JUL 2018 HAB605 JAN 2019 HAE019 JAN 2019 HAE964 JAN 2019 HAP987 JAN 2019 HBB681 JAN 2019 HBB952 JAN 2019 HBE186 JAN 2019 HCB084 JAN 2019 HCB972 JAN 2019 HCE266 JAN 2019 HCE980 JAN 2019 PERMA-HAND'' Silk Suture [Siliconized black braided] Product Code - 10Q07 Lots and Expiration Dates- GPB984 JUL 2018 GPE919 JUL 2018 HAP822 JAN 2019 HBP781 JAN 2019 HCP953 JAN 2019 HCR677 JAN 2019
Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
McGrath MAC2 Video Laryngoscope Blades   Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized.    Product Usage:  Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
40,900 blades (US); 16,000 blades (Foreign)
The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
DASANI (R) PURIFIED WATER, 16.9 FL OZ (1.06 PT) 500 mL, BOTTLED  BY A MEMBER OF THE COCA-COLA BOTTLERS' ASSOCIATION, ATLANTA, GA  30313, UPC 24pk- 2 4900003165 2
An equipment malfunction during production that may have led to the appearance of mold in some product.