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 Recall Z-0943-05 · Posted 2005-06-30
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFMG
Date Initiated2005-04-21
Date Terminated2006-07-19
Product Quantity107,832 sets
Reason for Recall
There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide and internationally to American Samoa and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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