Recalling Firm
RTI Surgical, Inc. (also dba RTI Biologics, Inc.)
University Of Miami Miller School of Medicine Tissue Bank

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
New Mexico, Georgia, Texas, Washington, California, New Jersey, Arkansas, Massachusetts, Pennsylvania, Michigan, Florida, Indiana, Virginia, Kentucky, Ohio, New York, Oregon, Illinois and Malaysia.
*** US: AK, ID, OR, WA; *** FOREIGN: Canada
Worldwide Distribution-US (nationwide) and the countries of Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, China, Croatia, Czech Republic, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Reunion, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Saudi Arabia, Switzerland, Syria, Taiwan, Thailand, France, Dominican Republic, Colombia, Turkey, Germany, Greece, Hong Kong, Denmark, Ecuador, Egypt, Estonia, Finland, Vietnam, Russian Federation, Iran, Iraq, Ireland, Israel, Italy, India, Indonesia, Japan, Jordan, Kenya, South Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldavia, Mongolia, Morocco, Nepal, Ukraine, United Arab Emirates, and United Kingdom
Nationwide throughout the US and Austalia
CA, FL, GA, IL, PA, MA, MI, MD, NY, NJ, NV, OR, TN, TX, VA, Puerto Rico, Barbados, Canada and Panama
US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
Worldwide distribution - USA nationwide, Austria, Australia, Belgium, Chile, Canada, Colombia, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Italy, Japan, Libya, Netherlands, Norway, Panama, Peru, Portugal, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
Indiana; Pennsylvania; Colorado; Louisiana; Delaware; Wisconsin; California; Nebraska; Florida
Distributed in the states of GA, MA, NC, NY & PA.
Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)
Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.
Worldwide Distribution - USA (nationwide) and Internationally to Belgium
Distributed to one customer/distributor with receiving locations in CO, NJ and MD. No foreign/military/govt/VA.
US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom
Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and W., and to the countries of : BELGIUM, GERMANY, GREAT BRITAIN, INDIA, ISRAEL, NETHERLANDS and SWITZERLAND.
Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.
US Distribution to the states of : MI, ND, SC, TN, and TX.
Distributed in Germany, Great Britain, and the Netherlands.
Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.

Product Description
Roach dry eviscerated salted Fish (Rutilus rutilus), Weight 0.365 Kg. Product is held in plastic packaging & shipped in 5 Kg (11 lb) boxes. Imported by: B&I Overseas Trading Inc, Van Nuys, California 91406. Distributed By: S and S Food Import Corp. 5337 Preston Court, Brooklyn, NY 11234 (www.ssfoodimport.com). Country of Origin Lithuania
ReadyBath Shampoo Caps, Scented are fabric-lined caps are pre-moistened rinse-free shampoo caps used to cleanse hair and are individually packaged in a film packet. There are 30 packets per carton.
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Philips Medical System Allura Xper X-Ray Angiographic
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
D.L. Jardine's MESQUITE BARBECUE SAUCE NET WT. 18 OZ. (510g) Distributed in Australia and New Zealand by Texan Imports Pty Ltd 19 Emperor Palace Kenthurst NSW 2156 Australia
D.L. Jardine's KILLER BARBECUE SAUCE NET WT. 18 OZ. (510g) Distributed in Australia and New Zealand by Texan Imports Pty Ltd 19 Emperor Palace Kenthurst NSW 2156 Australia
SHOTGUN WILLIE'S TEXAS CHILI SEASONING MAKES 1 1/2 QUARTS NET WT. 3.1 Oz (88g)
D.L. Jardine's Texas Chili Works ''THE WHOLE KIT N KABOODLE'' NET WT. 3 Oz (85g)
D.L. Jardine's Texas Chili Bag O'Fixins Kit Net Wt. 4 Oz (113g)
Jardine's FOUR BANDITOS SAMPLER in cardboard box with black and red graphics
GROUND CUMIN SEED, 50 LBS NET, ETO STERILE TREATED
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Red Blood Cells (Apheresis) Leukocytes Reduced
H-E-B Homestyle White Corn Tortillas 12ct. and 30 ct.
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Pecanettes, Net Wt 8oz (226.80 Grams), Shelled and Packed by: Stone Mountain Pecan Co., 1781 Hwy 78, Monroe, GA 30656.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
Fairway - Like No Other Market Organic Cranberry Low Fat Granola Net Wt. 12 oz. (340 g) Manufactured for Fairway Group Holdings Group, New York, NY 10027
Focal Sim radiation therapy treatment planning system
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Whole Foods Market Raw Macadamia Nuts packaged in 5.6 oz. clear plastic container with clear plastic lid; UPC: 7-23055-21415-3; 24 units per case
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Izzio Artisan Bakery Rev Lem/Poppy Muffins 3.5oz packaged individually and put into cardboard case with 90 muffins per case
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305. ADVIA Centaur/XP and ADVIA Centaur CP Progesterone Assay For in vitro diagnostic use in the quantitative determination of progesterone in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP system.
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522. ADVIA Centaur/XP and ADVIA Centaur CP Progesterone Assay For in vitro diagnostic use in the quantitative determination of progesterone in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP system.
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111. ADVIA Centaur/XP and ADVIA Centaur CP Progesterone Assay For in vitro diagnostic use in the quantitative determination of progesterone in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP system.
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
Herdez Chilpotle Peppers, 7oz., Item No. 52738, UPC 072878285131
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
SMARTSET GHV Gentamicin is a self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
LaRosa's Creamy Garlic Dressing, 1.5oz plastic packet. Labeled in part, ''INGREDIENTS: Soybean Oil, Water, Vinegar, Red Wine (preserved with Sulfites)***Packed for LaRosa's Inc, Cincinnati, OH 45238'' UPC 0 70200 80109
LaRosa's Italian Dressing, 1.5oz plastic packet. Labeled in part, ''INGREDIENTS: Soybean Oil, Water, Cultured ?Buttermilk, Distilled Vinegar, Romano Cheese, Part Skim Milk***Egg Yolk***Whey Protein Concentrate***CONTAINS: MILK EGGS***Packed for LaRosa's Inc, Cincinnati, OH 45238'' UPC 0 70200 85107
Vancomycin Hydrochloride Capsules, USP, 125 mg, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15, NDC 0591-3561-15
Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15

Code Info
Product Code: MSC095230. Lot Number: 14IE0027. Expiration Date: September 2016.
S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniCAT00140 MiniCAT00305 ENT00014 MiniCAT00148 ENT00039 ENT00076 MiniCAT00409 MiniCAT00179 ENT00014 MiniCAT00215 MiniCAT00309 ENT00035 MiniCAT00158 MiniCAT00386 MiniCAT00202 MiniCAT00324 ENT00127 MiniCAT00352 MiniCAT00396 MiniCAT00194 ENT00080 MiniCAT00171 MiniCAT00244
All DiscPac products are affected within expiry up to October 2017
Product Code; 2160, Lot number: M4132T636
Product Code; 22103, Lot number: M4132T614
Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.
Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334
Packet Code UB051615C & Packet Code UB052915C
Packet Code UB070115C, Packet Code UB072215C & Packet Code UB080415C
All lots manufactured as of February 24, 2015 are affected.
Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16
Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16

Reason for Recall
Blood products, collected from donors who were not adequately evaluated for residence in areas considered endemic for malaria, were distributed.
S&S Food Import Corp. recalled all packages of uneviscerated Dried Roach (Vobla) fish due to potential Clostridium botulinum contamination.
Human tissue allografts from two donors, possibly milled together during processing, were distributed under a single donor identifier.
The shampoo caps may contain broken needles.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
The recalled devices' labeling and instructions for use contain unapproved medical claims.
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Baxter Corporation is conducting a field action on Self-Righting Luer Tip Caps because the affected products were manufactured and shipped with a missing latex symbol on both single and case labels.
The recalling firm was notified by their supplier that ingredients used by the recalling firm contained undeclared peanuts.
Cumin may contain undeclared peanut protein.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from an ineligible donor, were distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Blood product, collected from an ineligible donor, was distributed.
Blood products, collected from a deferred donor, were distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Human bone allografts, mislabeled with an incorrect expiration date, were distributed.
Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
Defect: A hole or crack was found which may cause air to leak.
Human Corneas, recovered from an ineligible donor, were distributed.
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
Sole Grano LLC is recalling 12 oz. Fairway - Like No Other Market Organic Cranberry Low Fat Granola, because it may contain undeclared almond and wheat allergens.
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Izzio Artisan Bakery is voluntarily recalling a particular lot of Lemon Poppy Muffins because the product is undercooked and may contain undercooked egg.
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
MegaMex Foods is recalling Herdez Chilpotle Peppers product due to an undeclared wheat allergen.
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Incorrect size printed on the Milex Pessary Kit packaging label
Failed tablet specifications: One lot was found to contain oversized tablets.
Reports of formation of char adherent to the proximal part of the distal tip electrodes
DePuy Orthopaedics, Inc. is issuing a voluntary recall for one lot of SMARTSET GHV Gentamicin Bone Cement because the affected cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
The firm was notified by their customer that the ingredient statement on their packets of LaRosa Creamy Garlic Dressing and LaRosa Italian Dressing were switched. Therefore, rendering them to be misbranded due to undeclared Allergens of Milk, Egg and/or Sulfites.
Subpotent: Vancomycin 125 mg and 250mg capsules are being recalled due to subpotency.
Labeling: Illegible label. Writing is rubbing off of labels.
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Misbranded reagent red blood cells were distributed.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.