Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Recall Z-0845-05 · Posted 2005-05-17
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2005-02-28
Date Terminated2007-02-08
Product Quantity1,171,116 sets
Reason for Recall
Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
Firm Action
Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, 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. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits.
Root Cause
Other
Distribution Pattern
Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K003225SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVEBaxter Healthcare Corp · 2000-10-19K984381BURETROL SOLUTION SETSBaxter Healthcare Corp · 1999-02-19K962581STOPCOCK MANIFOLD GANGSBaxter Healthcare Corp · 1996-08-28K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETBaxter Healthcare Corp · 1996-06-21K791496LOW PLASTICIZER ADMINISTRATION SETSTravenol Laboratories, S.A. · 1980-04-08
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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