Recall Notice: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

On August 27, 2011, H & P Industries and the FDA issued a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

On August 3, 2011, the FDA notified healthcare professionals of a Class I recall of certain Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. Listed below are the affected product and lot numbers which were manufactured between April 14, 2011 and May 9, 2011.

Product Number Lot Number

CS-15192-IXM RV1034909
CS-15232-IXM RV1034911
CS-15272-IXM RV1034912
CS-15312-IXM RV1034913
CS-15422-IX RV1034914
CS-15502-IX RV1034915

The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck. Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information. For questions regarding this recall, contact Arrow International Inc. Customer Service at 1-(800)-233-3187. Click here for more information.

FDA Notice: Nulojix (belatacept) – Risk Evaluation and Mitigation Strategy (REMS)

On July 7, 2011, Bristol-Myers Squibb (BMS) informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the Central Nervous System. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen. It is recommended that healthcare providers verify the patient’s Epstein-Barr virus status before initiating therapy with Nulojix. BMS established the ENLiST Registry to further evaluate the safety profile of Nulojix. BMS encourages provider participation in the ENLiST Registry. Click here for more information.

Recall Notice: Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

On May 10, 2011, Defibtech, LLC a manufacturer of Automated External Defibrillators (AEDs) issued a recall of its Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. The company warned that AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive, and not breathing. To address this issue, Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction. Questions regarding this recall may be directed to Al Raebuck, Customer Service Manager, Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507. Click here for more information.

Recall Notice: Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

On May 6, 2011, The FDA notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor. There is the potential for the clips to become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. In 2006, the manufacturer added this contraindication to the Instructions for Use after receiving 15 reports of 12 injuries and three deaths which occurred between 2001 and 2005. Since the contraindication issued in 2006, there have been three more kidney deaths, all associated with the contraindicated use. The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes. It is used to permanently close bleeding vessels or tissue structures. See the FDA safety communication for a listing of affected model numbers, and recommendations for healthcare providers, hospital staff, and patients. Click here for more information.

Recall Notice: Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

On May 3, 2011, Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company product testing indicated that a tablet in this lot had a higher potency than anticipated. The affected lot number in the U.S. is 9H49374A with an expiration date of September 30, 2012. Any decrease of active ingredient in the mediation may increase the risk of clots which could lead to heart attack or stroke, and alternatively, if there is too much active ingredient, there is an increased risk of bleeding. It is recommended that patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affect lot and if so, should consult their physician for additional medical advice. For further information related to this recall contact: Stericycle, Inc. at (866) 918-8739. Click here for more information.

Recall Notice: Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin

A Class I Recall has been issued for Roche ACCU-CHEK FlexLink Plus Infusion Sets. There is the potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If gone unnoticed, this can result in the under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death. Of important note, this recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can be continued as directed by a physician or other qualified healthcare provider. Roche requests that its consumers stop using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products. Patients are encouraged to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. Click here for more information.

Recall Notice: Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

Tested Samples of Soladek Vitamin Solution have been found to contain elevated levels of vitamin A and vitamin D that were many times the recommended daily allowance for these vitamins. The intake of excessively high levels of these vitamins poses a risk to human health. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Soladek Vitamin Solution is marketed with claims that the product treats "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy." The product is sold in a box labeled in Spanish and containing a vial of the solution. Those in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately. Click here for more information.

Recall Notice: American Regent Injectable Products: Recall - Visible Particulates in Products

On March 18, 2010, American Regent, Inc. initiated a recall of certain injectable products manufactured by the company which have the potential for glass to flake from the product vial into the injection solution. The recalled products include:

[03/16/2011 - Press Release3, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release4, Bacteriostatic Sodium Chloride - American Regent]
[03/15/2011 - Press Release5, Concentrated Sodium Chloride - American Regent]
[02/04/2011 - Press Release6, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release7, Potassium Phosphates - American Regent]

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection8]
[12/29/2010 - Sodium Bicarbonate Injection9]

Glass delamination (separation) can occur with high pH solutions. Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics, and other healthcare facilities should not use recalled American Regent products. Recalled products should be immediately quarantines for return. Refer to the highlighted Press Releases above for specific lot numbers recalled.
Click here for more information.

Recall Notice: H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

On March 18, 2011, H&P Industries, Inc. initiated a voluntary recall of ALL LOTS of Povidine Prep Pads manufactured by their company, but which are privately labeled for many accounts. Recent testing has shown of Elizabethkingia meningoseptica on the pads. Use of contaminated Povidine Prep Pads could lead to life threatening infections, especially in at risk populations, including neonates, immune suppressed pateints, and surgical patients. Providine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns, and are labeled as an antiseptic for preparation of the skin prior to surgery. The pads were distributed nationwide to healthcare customers ans are packaged in individual packets in a box of 100 packets Healthcare organizations should contat H&P Industries at (262) 538-2900 to arrange a return. Any consumer in possession of these pads should not use the product.
Click here for more information.

Recall Notice: American Regent Injectable Products: Recall - Visible Particulates in Products

On March 18, 2010, American Regent, Inc. initiated a recall of certain injectable products manufactured by the company which have the potential for glass to flake from the product vial into the injection solution. The recalled products include:

[03/16/2011 - Press Release3, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release4, Bacteriostatic Sodium Chloride - American Regent]
[03/15/2011 - Press Release5, Concentrated Sodium Chloride - American Regent]
[02/04/2011 - Press Release6, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release7, Potassium Phosphates - American Regent]

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection8]
[12/29/2010 - Sodium Bicarbonate Injection9]

Glass delamination (separation) can occur with high pH solutions. Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics, and other healthcare facilities should not use recalled American Regent products. Recalled products should be immediately quarantines for return. Refer to the highlighted Press Releases above for specific lot numbers recalled.
Click here for more information.

Recall Notice: B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive

On February 1, 2011, B. Braun Medical Inc. and the FDA issued a Class 1 Recall of its Outlook 400ES Safety Infusion System, Model# 621-400ES. Infusions systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. It is encouraged that customers deactivate the wireless communication on their pumps and return them to the manufacturer. Any questions can be directed to B. Braun Medical Inc. at (972) 245-2243. Click here for more information.

Recall Notice: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors

On January 14, 2011, Fresenius Medical Care North America announced a voluntary recall notice of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors (Part Numbers 03-2695-9 and 03-2795-7) for use with the Blood Volume Monitor (BVM), due to reports of arterial line kinks. These kinks may manifest as arterial pressure alarms or be mistaken as access problems. There is also the potential for kinking to cause hemolysis can result in serious injury or death. The recall includes the following part numbers and lot numbers which were sold in the U.S. and Canada.

Part Number: 03-2695-9
Lot Numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180

Part Number: 03-2795-7
Lot Numbers: 09JR01174, 09JR01229, 09NR01139, 10KR01801

Customers who have the affected lots of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the BVM which are being recalled should discontinue their use immediately and return product to Fresenius Medical Care. Clinic Managers, Unit Administrators and/or distributors with questions may contact Fresenius Medical Care Customer Service Team at 1-800-323-5188 in USA (7am-6pm CST, 5 days per week, with after-hours emergency support) and 1-888-709-4411 in Canada.

In addition, it is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

On January 7, 2011, The Triad Group issued a recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. The recall pertains to all such products marked as either STERILE or non-sterile. The recall was initiated over concerns of possible product contamination with Bacillus cereus. Continued use of affected product could put at-risk patients at risk of developing life-threatening infections.
Recalled lots were distributed nationwide to retail pharmacies and sold in individual packets and in boxes containing 100 packets. The affected alcohol prep pads, alcohol swabs, and alcohol swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place of purchase for a full refund. Click here for more information.

Recall Notice: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall

On January 5, 2011, AngioScore Inc. issued a recall of certain AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platforms manufactured by the company. The recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. The devices are being recalled due to a design defect which can cause unintended fracture and peeling, resulting in fraying of the bond and/or detachment of the distal end of the scoring element. AngioScore Inc. is advising customer to immediately discontinue use of any recalled product. Not doing so may lead to retained device fragments or arterial injury that could lead to the need for surgical intervention or death. Click here for more information.

Recall Notice: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials

On December 23, 2010, American Regent issued a voluntary recall of its Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials due to the possibility of vials containing particulate matter. If use is not discontinued, potential adverse health events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. For this reason, American Regent is undertaking this recall in consideration of the potential for safety issues if any unapproved product is administered to patients. To access recalled product lot numbers, expiration dates, and additional instruction please, reference the Recall Notice in the following link.Click here for more information.