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.
Recall
- Recall Number
- Z-1100-05
- Event Number
- 32588
- Firm
- Baxter Healthcare Corp. Rt.
- FEI Number
- 1416980
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 6, 2005
- Posted
- August 6, 2005
- Terminated
- January 31, 2007
- Address
- 120 & Wilson Rd, Round Lake, IL, 60073
Description
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.
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.
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.
Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.
4,176 sets