—#25167

Product

Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546, Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K925126
Affected lot / code info: All lots received prior to 10/23/2002

Why it was recalled

The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2002-10-17
Posted by FDA: 2003-02-06
Terminated: 2004-02-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.