—#39346

Product

Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K961495
Affected lot / code info: Lot FC04058

Why it was recalled

Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837.

Recalling firm

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

Distribution

Distribution pattern: Arkansas, Florida, Texas, North Carolina, Wisconsin and Japan.

Timeline

Recall initiated: 2005-05-31
Posted by FDA: 2005-07-28
Terminated: 2006-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.