Recalling Firm
Schindele Enterprises dba Midwest Wholesale
Maquet Datascope Corp - Cardiac Assist Division
The American National Red Cross - Southern Region
DCI Donor Services dba Sierra Donor Services

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

Distribution Pattern
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
US Nationwide Distribution in the states of: AR, CA, CO,DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MI, MN, MO, NC, NV, NY, OH, OK, TN, TX, UT, WA, WI, WY. OUS: ARGENTINA. AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGRY, INDIA, IRA, ISRAEL, ITALY, JAPAN, KAZAKTSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PANAMA, POLAND, QATAR, ROMANIA, RUSSIAN, FDRATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, TAIWAN, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.
Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan. .
distributed to one consignee's warehouse located in Fairfield, OH
Worldwide Distribution - USA (nationwide), worldwide to approximately 104 countries.
Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Connecticut; Pennsylvania; New York; Massachusetts; New Jersey
Worldwide Distribution - USA (nationwide) and Canada.
Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey.
Nationwide Distribution including GA, KY, and MI.
Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL ITALY JAPAN LIBYA MALAYSIA NEPAL NETHERLANDS NEW ZEALAND PERU POLAND PORTUGAL QATAR ROMANIA RUSSIA RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
US Nationwide Distribution in the state of Mississippi.
Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
FL, GA, IN, MD, MI, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA and Puerto Rico
Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates
AL, DE, FL, GA, MD, NC, NJ, PA, SC, TN, VA OR, Mt, AL, CA, WA
The product was distributed to KS, IN and IA.
Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.
Distributed in the states of GA, FL, NY, NV, and MA.
Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.

Product Description
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.
XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only.
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
PDP reads in part ''***GOOD FOOD MADE SIMPLE***breakfast in a bowl *** SOUTHWESTERN VEGGIES***'' UPC 0 80618 41801 5
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump Product Usage: The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
''Emparedados Boricua, Pollo & Queso (Chicken & Cheese), Net Wt. 6.5 oz, Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''
''Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich), net Wt. 7.6 oz (220 g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''
''Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich), Net Wt. 7.6 oz (220g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''
''Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich), Net Wt. 8 oz. (230g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''
Esmark Elastic Bandage (Sterile), 4'' x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
JK Bariatric Beds, True Air Technologies, Inc.
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Human Immunodeficiency Virus Type 1 and/or HCV and/or HBV (Nucleic Acid Pooled Testing/Syn)
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala
QVAR (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs
Meijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15; 24 bottles per case, 6-4packs
Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161
Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178
Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-052159701215
Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated
Blue Bunny Premium Ice Cream, Bordeaux Cherry Chocolate, 1.75 quart. Packaged in 4/56-oz carton cases. Item # 745152, UPC 070640034123. Manufactured by Wells Enterprises, Inc., Le Mars, IA.
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
On cap 100% Spring Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Source Boiling Spring, Oakland, MD 21550 On bottle side: Tyler Mountain Water & Coffee In 3 gallon and 5 gallon plastic bottles
On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 15239 Processed by Reverse Osmosis, Steam Distillation, Micro-filtration, Ozonation, UV *Minerals added for taste On Bottle side: Tyler Mountain Water & Coffee In 4 gallon and 5 gallon plastic bottles
Platelets Pheresis Leukocytes Reduced Irradiated
Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack
Lipton Pure Leaf Iced Tea Sweet Tea 18.5OZ PL 6 Pack
Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 6 Pack
Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 12 Pack
Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack
Lipton Pure Leaf Iced NTS Peach Tea 12 Pack
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.

Code Info
12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.
1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.
12-ct.bottle, Lot GP808, Exp. 10/16, 1-ct. blister Lot BN030613, EXP 020615
Catalog Number: 139 3396, Lot Number: 1590
Product Number: DYNJ05116A . Lot Number: 13LA1009.
Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0.
Item # 133244 (6 pk) and Item # 134072 (12 pk) with codes: XXXXGG03034, XXXXGG03044, and XXXXGG03054. Manufactured on: 03/03/14, 03/04/14, and 03/05/14. BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
Item # 133245 (6 pk) with codes: XXXXGG03064 Manufactured on: 03/06/14 BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
Item # 133246 (6 pk) with codes: XXXXGG03034 and XXXXGG03044 Manufactured on: 03/03/14 03/04/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
Item # 134073 (12 pk) with codes: XXXXGG03034, XXXXGG03044,and XXXXGG03064. Manufactured on: 03/03/14, 03/04/14, and 03/06/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
Item # 137642 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Jun 30 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
Item # 137643 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Sept 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14)
(Material number 10549894) with serial numbers 5000 through 5029.
Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)

Product Quantity
500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles
583 units Total (357 units domestically & 226 units internationally)
2 kits (Master Lot 624104) and 5 kits (Master Lot 614564)

Reason for Recall
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, which was not tested for pH and platelet count, was distributed.
Blood products, for which the sample tubes for NAT testing may have been stored at an unacceptable temperature, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual amount of movements. This issue may lead to an inadequate dose of muscle relaxants. This issue may occur when the E-NMT-01 module is plugged into the CARESCAPE or the Datex-Ohmeda S/5 Anesthesia monitor.
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%
Raw material supplier accidently added sodium benzoate to the salsa used in manufacturing the finished product. Sodium benzoate was not declared on the ingredient statement of both the raw material and finished product.
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-ray with the assumption that the component was echogenic, the needle would appear less prominently than expected but would still be visible.
Undeclared eggs in Chicken (fully cooked)/Cheese sandwich.
Undeclared soy coming from the Cheese Swiss.
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Blood products, collected from a donor with Erythrocytosis, were distributed.
Blood product, collected from a donor with an incomplete donor suitability determination, was distributed.
Pool Cryoprecipitated AHF, not meeting quality control specifications, were distributed.
Naturalyte Liquid Bicarbonate maybe contaminated
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
Blood product, which had a low pH value, was distributed.
In-vitro diagnostics, with mixed master lots, were distributed.
Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Fisher and Paykel Healthcare is recalling the Infant Nasal CPAP Prong because it has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Grasper jaw may break when force is applied to the jaw
The Irrigation Clips were assembled with the incorrect (smaller) clips.
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
The hose could separate from the blanket.
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.
Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb
Defective Delivery System; defective valve
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.
H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation.
Product has elevated levels of coliforms
Blood products, which were not quarantined after receiving post donation information concerning receipt of a tattoo, were distributed.
The product may contain egg which is not listed on the ingredient label.
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
For Spring Water and Purified Water bottled 4/17 - 18/2014, Outside lab results were positive for Coliforms non-speciated E. coli.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, which were not tested for pH and platelet count, were distributed.
Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product.
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing acceptance criteria for a required drift test.
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Labeling: Missing Label; The label on the immediate bottle is missing.