TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engin
FDA device recall Z-0579-2008 · posted 2008-02-26 · Terminated
Recall details
- Recalling firm
- Tenet Medical Engineering Inc
- Reason for recall
- Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
- Action taken
- TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JEB
- Quantity affected
- 160 units.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-11-23
- Date posted
- 2008-02-26
- Date terminated
- 2009-05-01
- Location
- Calgary, Canada
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