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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter Interlink System

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 Class 1 Recall
Baxter Interlink System
see related information
Date Posted February 06, 2003
Recall Status1 Open
Recall Number Z-0505-03
Recall Event ID 25088
Product Baxter Interlink System Minivolume Extension Set; catalog 1C8412; Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information All lots received prior to 10/23/2002
Recalling Firm/
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
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. .
Quantity in Commerce 679,968 units
Distribution 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.

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55