Class 2 Device Recall Baxter Spinal Anesthesia Trays

• Date Initiated by Firm: March 28, 2005
• Date Posted: May 06, 2005
• Recall Status: Terminated on March 04, 2008
• Recall Number: Z-0800-05
• Recall Event ID: 31491
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: 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
• Code Information: product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333; product code 1T2450, lot GD809590; product code 1T2451, lot GD801282; product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620; product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335; product code 2T0188, lot GD812255; product code 2T0298, lot GD809632; product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699; product code 2T0458, lot GD811448; product code 2T0555, lots GD810622, GD809400; product code 2T0618, lot GD811182; product code 2T0642, lots GD810655, GD808931; product code 2T0643, lot GD811455; product code 2T0661, lots GD808956, GD809434; product code 2T0770, lot GD810275; product code 2T0783, lot GD810101; product code 2T0784, lot GD809830; product code 2T2001, lot GD810788; product code 2T2007, lots GD810416, GD812156; product code 2T2008, lot GD809467; product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026; product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127; product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360; product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 127,340 trays
• Distribution: Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.