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Product Recalls and Bulletins  Privacy Notice

Current Product Recalls

Below are the details of the most recent product recalls.
SeQuel Eclipse Oxygen System Model 1000

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.

Orchid Fresh II (This is not a product recall. It is a product advisory.)

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.

One Touch Ultra Test Strips 100-count (This is not a product recall. It is a product advisory.)

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.

Medtronic Quick-SetŪ infusion sets used with MiniMed ParadigmŪ insulin pumps

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.