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Terminated

Portex Continuous Epidural tray Ref 4948-17

FDA Recall Z-0211-2007 · Posted 2006-11-22

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeCAZ
Date Initiated2006-10-27
Date Terminated2012-05-22
Product Quantity540 units

Reason for Recall

Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

Firm Action

Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.

Root Cause

Other

Distribution Pattern

Nationwide and Panama

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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