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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Combined Epidural Anesthesia Trays

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 Class 2 Device Recall Baxter Combined Epidural Anesthesia Trayssee related information
Date Initiated by FirmJanuary 10, 2006
Date PostedFebruary 08, 2006
Recall Status1 Terminated 3 on March 17, 2008
Recall NumberZ-0508-06
Recall Event ID 34381
Product Classification Anesthesia Conduction Kit - Product Code CAZ
ProductBaxter Combined Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing a spinal needle, an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the spinal needle or epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
Code Information product code 1T5771, lot GD822783;  product code 2T2076, lot GD822932;  product code 2T2097, lot GD822940;  product code 2T2201, lot GD822817;  product code 2T2215, lot GD822825;  
FEI Number 1416980
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter 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
ActionBaxter 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 Commerce1,450 trays
DistributionNationwide
Total Product Life CycleTPLC 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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