Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case
FDA Recall Z-0515-03 · Posted 2003-02-06
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2002-10-17
Date Terminated2004-02-04
Product Quantity198,816 units
Reason for Recall
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Firm Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
Root Cause
Other
Distribution Pattern
Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.
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.