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Terminated

4950-16 Portex Epidural Mini-pack

FDA Recall Z-0245-06 · Posted 2005-11-30

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeCAZ
Date Initiated2005-11-17
Date Terminated2012-05-08

Reason for Recall

Tray may contain holes compromising the sterility of the device

Firm Action

Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965017REGIONAL ANESTHESIA TRAYSSmiths Industries Medical Systems, Inc. · 1997-03-14

Official Source

View FDA Recall →

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

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