Recall issued:  4-7-10
Manufacturer:  Wheelchairs of Kansas and ElectriCord Manufacturing Company
Product numbers:  Specific product numbers not available. For questions and replacement cords, please contact Home Care Medical’s purchasing department at 262-957-5585 or 262-957-5595. 

Customers who have purchased electrical powered products manufactured by Wheelchairs of Kansas should check to see if the power cord has a black plastic bridge that connects the terminal prongs.  If so, they should further check for cracked prongs, an outer sheath that is visibly burnt, a black residue or signs of excessive wear and tear.  If any of these signs are evident, they should stop using the product and contact Home Care Medical for a replacement electric power cord.  The FDA advises that the cords may cause electrical shock, delay in setup and therapy, interruption in therapy and device failure.  The cords may also cause fires in an oxygen-rich environment.   Depending on the product and therapy, failure of the cord may potentially lead to serious adverse health consequences, including death.
For questions and replacement cords, please contact Home Care Medical’s purchasing department at 262-957-5585 or 262-957-5595. 

Recall issued:  4-22-10

Manufacturer:  GE Healthcare

Product numbers:  Please refer to manufacturer’s recall notice

GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards.  It is possible that the external power supply could leak electrical current.  This current could cause third degree burns or an abnormal heart rhythm that, if untreated, could lead to death.

For questions please contact GE Healthcare Technical Support at 1-800-558-7044 or Home Care Medical’s purchasing department at 1-800-369-6939 ext. 585 or ext. 595.

Recall issued:  4-13-10
Manufacturer:  Covidien
Product numbers:  Recall applies to the 62 product codes and associated lot numbers listed in Tables 1 and 2 found on the manufacturer’s recall notice.

Customers have reported serious adverse health consequences that may be linked to certain cuffed Shiley™ tracheostomy tubes, in which the cuff does not hold air as a result of leaks in the pilot balloon inflation assembly.  If a cuff does not hold air, ventilation will be adversely affected and the tracheostomy tube might require immediate replacement. 

If a cuffed Shiley™ tracheostomy tube from an affected lot is already in use in a patient, it is recommended that the tube be replaced with a tube that is not included in the affected lots as soon as the patient’s physician determines it is clinically appropriate.  If the physician advises leaving the tracheostomy tube in place until a more acceptable replacement opportunity occurs, it is strongly advised that the frequency and intensity of monitoring the cuff inflation system be increased.

For questions, please contact Home Care Medical’s purchasing department at 262-957-5585 or 262-957-5595.

Recall issued:  11-12-09
Manufacturer:  SeQuel Technologies
Product numbers:  Model 1000.  Serial numbers have been provided to home care providers.

SeQuel Technologies has identified that some Eclipse Oxygen System (Model 1000) units may experience premature failure of an electrical component that could lead to a temporary power interruption when operating from the Power Cartridge.  A temporary power interruption would cause the unit to sound an alarm and shut down.  If the patient does not have access to an alternate supply of oxygen or access to AC or DC power then this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences. 

This electrical component is being replaced.  SeQuel has provided Home Care Medical with serial numbers of affected units.  If you have one of the affected units, Home Care Medical will contact you to arrange for service of the  unit.

Please report any issues with the Eclipse Oxygen System (Model 1000) to Home Care Medical's service department at 262-786-9870.

Product Advisory issued: 10-8-09                                                                                                        Manufacturer:  Care-Tech Laboratories, Inc.
Product numbers: HLT115-03

Neither the FDA nor Care-Tech is aware of any reports of injury or illness related to the use of this product and the FDA has not requested that the product be recalled.  Concerns raised by the FDA:  "Products have not been manufactured, processed, packed and held consistent with current good manufacturing practice for drugs, which makes them presumptively adulterated under the law, even where, as here, no finished product has been found defective."  Care-Tech has suspended manufacturing and distribution of this product to address these concerns.  For more information call 262-786-9870 ext. 202.

Product Advisory issued:  11-23-09
Manufacturer:  LifeScan
Product numbers:  LSN020245  lot numbers 2960566 and 2960878

It has been determined that two lots of test strips may contain a very small number of damaged test strip containers.  A defect in the bottom of the vial does not penetrate the inner portion of the vial which contains the test strips.  Due to the fact that the test strips are not exposed, performance of the test strips is not impacted when vials are stored and used as instructed.  As with all strip containers, users are advised:  "Do not use your One Touch Ultra Brand Test Strips if your vial is open or damaged in any way as this could lead to error messages or inaccurate blood glucose values."  For more information or to report damaged vials visit www.OneTouchProductID.com.

Recall issued:  7-9-09
Manufacturer:  Medtronic
Product numbers:  Lot numbers starting with the number 8 with the following reference numbers:   MMT-396, MMT-397, MMT-398 and MMT-399.

Medtronic will be contacting affected customers directly, sending each a package containing a recall notice, one box of pump sets (30-day supply) and a call tag to return recalled products.  When Medtronic receives the returned sets, the customer will receive, directly from Medtronic, one box every three weeks until the entire return is replenished.  Until Medtronic's usable stock is restored, all new orders will be rationed at the rate of one box every three weeks.

Click here for information from Medtronic on important therapy considerations.