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Terminated

Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20

FDA Recall Z-0166-04 · Posted 2003-11-27

Recalling FirmPortex Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2003-10-10
Date Terminated2006-05-02
Product Quantity2600 units

Reason for Recall

Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

Firm Action

Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.

Root Cause

Other

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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