—#41101

Product

Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 3/4'', Total Volume 0.75 mL, Total Length 10''; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K961495
Affected lot / code info: product code 2N3709, lots FC04052, FC04058, FC04059, FC05006, FC05009; extended to include lots FC05018, FC05023, FC05029

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 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: 2005-08-03
Posted by FDA: 2005-08-30
Terminated: 2008-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.