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.
Monday, March 21, 2011
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.
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.
[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.
Thursday, March 3, 2011
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.
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