—#38524

Product

Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K022895
Affected lot / code info: product code 3C0062s, lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192

Why it was recalled

There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and internationally to American Samoa and Venezuela.

Timeline

Recall initiated: 2005-04-21
Posted by FDA: 2005-06-30
Terminated: 2006-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38524. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.