Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre

FDA device recall Z-0800-05 · posted 2005-05-06 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.

Action taken

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

Status

Terminated

Product code

CAZ

Quantity affected

127,340 trays

Distribution

Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela

Date initiated

2005-03-28

Date posted

2005-05-06

Date terminated

2008-03-04

Location

Round Lake, IL