Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a

FDA device recall Z-1099-05 · posted 2005-08-06 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FPA

Quantity affected

18,816 sets

Distribution

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

Date initiated

2005-07-06

Date posted

2005-08-06

Date terminated

2007-01-31

Location

Round Lake, IL

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