—#43484

Product

Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution set: 84'', 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 21'', 3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6'', 0.5 mL Vol with microvolume tubing and retractable T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K022895, K921899, K962581, K984381
Affected lot / code info: product code 3C0172, lot GR230631

Why it was recalled

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

Root cause (FDA determination)

Other

Action the firm took

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 additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2005-12-15
Posted by FDA: 2006-03-24
Terminated: 2008-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.