Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall Z-0800-05 · Posted 2005-05-06
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeCAZ
Date Initiated2005-03-28
Date Terminated2008-03-04
Product Quantity127,340 trays
Reason for Recall
The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.
Firm Action
Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy the needle in the tray and replace it with the replacement needles when the tray is opened prior to the procedure.
Root Cause
Other
Distribution Pattern
Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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