Recall Z-0646-06 · FMG Stopcock, I.V. Set

Baxter Healthcare Corp.

Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension set: 19'', 3.2 mL Vol., with injection site and male Luer Lock adapter, manifold extension set: 46'', 6.2 mL Vol, male luer adapter, and minivolume extension set: 10'', 0.7 mL Vol, injection site and s

Date	Mar 24, 2006 (initiated Dec 15, 2005)
Status	Terminated
Reason	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Root cause	Other
Action	Baxter sent Urgent Product Recall letters dated 8/3/05 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 microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. 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. Baxter extended the recall to include
Quantity	5,856 sets
Distribution	Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K022895	ELCAM STOPCOCKS AND MANIFOLDS Medical Device Consultants, Inc., Oct 18, 2002
K811078	RADIATION STERILIZED ADMIN. SET Travenol Laboratories, S.A., Jul 2, 1981
K921899	INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET Baxter Healthcare Corp, Apr 20, 1993
K924721	BAXTER SOLUTION ADMINISTRATION SETS Baxter Healthcare Corp, Jul 20, 1993
K962581	STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp, Aug 28, 1996