—#25456

Product

Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: KSB — Set, Transfer (Blood/Plasma)
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K881321
Affected lot / code info: Lots GR182865, GR184309, GR186569

Why it was recalled

Leakage may occur at the inlet port

Root cause (FDA determination)

Other

Action the firm took

The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2002-12-18
Posted by FDA: 2003-01-16
Terminated: 2003-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.