Baxter Combined Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing

FDA device recall Z-0508-06 · posted 2006-02-08 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CAZ

Quantity affected

1,450 trays

Distribution

Nationwide

Date initiated

2006-01-10

Date posted

2006-02-08

Date terminated

2008-03-17

Location

Round Lake, IL