FDA Recall Terminated

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.

Recall: Z-0509-06 · Initiated January 10, 2006

Recall

Recall Number
Z-0509-06
Event Number
34381
Firm
Baxter Healthcare Corp. Rt.
FEI Number
1416980
Product Code
CAZ
Status
Terminated
Root Cause
Other
Initiated
January 10, 2006
Posted
February 8, 2006
Terminated
March 17, 2008
Address
120 & Wilson Rd, Round Lake, IL, 60073

Description

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.

Reason

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.

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.

Distribution

Nationwide

Quantity

2,200 trays