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Terminated

TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

FDA Recall Z-0577-2008 · Posted 2008-02-26

Recalling FirmTenet Medical Engineering Inc
Recall StatusTerminated
Product CodeJEB
Date Initiated2007-11-23
Date Terminated2009-05-01
Product Quantity300 units.

Reason for Recall

Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.

Firm Action

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

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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