Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0507-06

Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only...

Baxter Healthcare Corporation / initiated 2006-01-10 / Terminated

Baxter Healthcare Corp. began a recall of Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0507-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
Product
Baxter Continuous 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.
Product code
CAZ Anesthesia Conduction Kit
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 root cause
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
1,070 trays
Distribution
Nationwide
Product codes and lots
product code 1T1571, lot GD822999;  product code 1T1672, lot GD822908;  product code 1T2574, lot GD822791;  product code1T2673, lot GD822619;  product code 1T5681, lot GD822536