—#43706

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.

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: product code 1T1571, lot GD822999; product code 1T1672, lot GD822908; product code 1T2574, lot GD822791; product code1T2673, lot GD822619; product code 1T5681, lot GD822536

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2006-01-10
Posted by FDA: 2006-02-08
Terminated: 2008-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43706. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.