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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Epidural Anesthesia Trays

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  Class 2 Device Recall Baxter Epidural Anesthesia Trays see related information
Date Initiated by Firm January 10, 2006
Date Posted February 08, 2006
Recall Status1 Terminated 3 on March 17, 2008
Recall Number Z-0509-06
Recall Event ID 34381
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product Baxter Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
Code Information product code 2T0609, lot GD822585;  product code 2T2263, lot GD822874;  product code 2T2367, lots GD822551 and GD822981;  product code 2T2386, lot GD822452
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 BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
FDA Determined
Cause 2		 Other
Action Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in Commerce 2,200 trays
Distribution Nationwide
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.
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