Recall issued:  4-15-11 and 7-15-11
Manufacturer:  Smith & Nephew
Product numbers: Numerous product numbers and lot numbers.

If you have any of the products listed above, please discontinue use and contact Home Care Medical’s Purchasing Department at 800-369-6939 ext. 595.

Notification issued:  3-30-11
Manufacturer:  GE Healthcare
Part numbers:  Plastic enclosure on the external power supply of the TruSat Pulse Oximeter. There are three affected external power supplies.  Affected part numbers are:TR9CE1250LRPD-Y-MED, TR9CE1250LR2P-Y-MED, TR9HE1250LRDP-Y-MED

The plastic enclosure on the external power supply for the TruSat Pulse Oximeter may break, exposing the electrical board and line voltage.  The exposed electrical board and line voltage pose a risk to the user or caregiver if they touch the power supply while it is plugged in. Touching the broken power supply while plugged in may result in a burn or electrical shock. Additionally, the plastic enclosure of the external power supply used with the TruSat Pulse Oximeter may get hot and become deformed.  The hot surface poses a risk to the user or caregiver and may result in a severe burn.

If you see visible signs of external power supply plastic enclosure breakage, immediately unplug the power supply, discontinue use and contact Home Care Medical’s Respiratory Intake Department at 262.786.9870, ext. 208. DO NOT TOUCH AN EXPOSED ELECTRICAL BOARD. GE Healthcare will provide you with a replacement power supply in August of 2011 at no cost to you.  

If there are no visible signs of enclosure breakage, the device can be operated safely by securing the power supply.  Securing the power supply will prevent a fall, which could cause breakage. If the power supply does fall, ensure that it is unplugged from the electrical socket prior to touching or examining the enclosure.

If the surface of the external power supply enclosure feels unusually warm to the touch during use or becomes deformed, immediately unplug the external power supply from the electrical socket, discontinue use and contact Home Care Medical’s Respiratory Intake Department at 262.786.9870, ext. 208. LET THE EXTERNAL POWER SUPPLY COOL DOWN BEFORE HANDLING THE EXTERNAL POWER SUPPLY.  

If the external power supply plastic enclosure does not feel unusually warm and is not showing signs of deformation, the device can be operated safely.  If in doubt, please discontinue use of the device.

Power adaptor (also referred to as the transformer) used with the Medela Pump In Style Advanced (PNSA) family of breast pumps.

Notification issued:  4-1-11
Manufacturer:  Medela, Inc.
Product numbers:  Power adaptor as a component of Pump In Style Advanced (PNSA) family of breast pumps.

When not handled properly, a small percentage of these power adaptors can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the cord. Refer to the manual you received with your breast pump for properly handling of the cord. The power adaptor is UL-approved for use with the PNSA and is safe for use if not damaged.  There have been no reported injuries related to the power adaptor.  Should a power adaptor show signs of damage, discontinue use and contact Medela Customer Service at 888-633-3528 or visit www.medelapoweradaptorhelp.com.

If you have questions, you can also contact Home Care Medical’s Purchasing Department at 800-369-6939 ext. 595.  

Recall issued:  2-1-11
Manufacturer:  Roche Insulin Delivery Systems
Product numbers:  All lots of ACCU-CHEK FlexLink Plus Infusion Sets

Roche Insulin Delivery Systems is conducting a recall on all lots of ACCU-CHEK FlexLink Plus Infusion Sets.  This recall is initiated due to the potential for under delivery of insulin due to a kinked/bent cannula when inserting.  If this remains unnoticed, it can result in elevation of blood glucose levels.

If you have affected product discontinue use and please contact Home Care Medical’s Purchasing Department at 800-369-6939 ext. 595. 

Recall issued:  1-19-11
Manufacturer:  Triad Group
Product numbers: All Triad Alcohol Prep Pads

Triad Group is conducting a recall on all lots of Triad Alcohol Prep Pads.  This recall has been initiated due to concerns about potential contamination of the alcohol prep pads with an objectionable organism which could cause patient infection.

If you have Triad Alcohol Prep Pads, please contact Independence Medical Customer Service at 1-800-860-8027. For other related questions please contact Home Care Medical’s Purchasing Department at 800-369-6939 ext. 595.

Recall issued:  2-22-11
Manufacturer:  Animas Corporation
Product numbers:  Cartridges shipped between 11-30-10 and 1-4-11 with lot numbers: B201575, B201576, B201581, B201582, B201583

Animas Corporation has learned that some of the 2.0 mL insulin pump cartridges (lot numbers listed above) shipped between the dates listed above can leak insulin, resulting in the delivery of less insulin than intended.  In addition, if the cartridge has a leak, the pump may not alarm if there is an occlusion in the infusion set.  Under-delivery of insulin can cause high blood glucose and/or diabetic ketoacidosis.  These are serious conditions that can cause severe health impact, including death.

Please be assured that the issue identified relates solely to the cartridges contained in the lots listed above.  There is not a problem with the pump or the infusion set.

Affected patients were also notified of this recall by email and letter.  Animas is providing these patients with a replacement supply of insulin cartridges as well as instructions for returning their affected cartridge supply.

If you have questions, please contact Animas at 855-254-5668. For other related questions please contact Home Care Medical’s purchasing department at 800-369-6939 ext. 595. 

Recall issued:  12-30-10
Manufacturer:  Triad Group
Product numbers:  Lot numbers beginning with: 7, 8, 9 or 0

Triad Group is conducting a recall on all lots of Sterile Lubricating Jelly remaining within their labeled expiration dating (three years), including all lot numbers beginning with 7, 8, 9 or 0.  This recall has been initiated due to concerns expressed by the Food & Drug Administration regarding the validation of the gamma sterilization cycles for these products.  Use of inadequately sterilized product could result in patient infection.  If you find you have affected product, please discontinue use and contact Independence Medical Customer Service at 1-800-860-8027 for return instructions. 

For other related questions please contact Home Care Medical’s purchasing department at 1-800-369-6939 ext. 595.