—#40733

Product

Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964850
Affected lot / code info: product code 1C8462, lots GR219444, GR223255, GR224659, GR227140;

Why it was recalled

Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter 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: Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.

Timeline

Recall initiated: 2005-07-06
Posted by FDA: 2005-08-06
Terminated: 2007-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40733. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.