Baxter Interlink System Y-Type Minivolume Extension Set… recallZ-1103-05 · Baxter Healthcare Corp. · initiated Jul 6, 2005

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number

Z-1103-05

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jul 6, 2005

Posted by the FDA

Aug 6, 2005

Recalling firm

Baxter Healthcare Corp.

Quantity

840 sets

Product code

FPA

FDA submissions

K791496

Distribution

Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.

Product description

Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

Other devices under the same FDA submission

1 device cleared under K791496 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NA 2C1145

  Baxter International Inc. · Set, administration, intravascular
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 32588).

• Z-1099-05 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerf…
• Z-1102-05 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, …