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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 Device Recall Baxter Interlink Systemsee related information
Date Initiated by FirmOctober 17, 2002
Date PostedFebruary 06, 2003
Recall Status1 Terminated 3 on February 04, 2004
Recall NumberZ-0507-03
Recall Event ID 25088
510(K)NumberK925126 
Product Classification Set, Administration, Intravascular - Product Code FPA
ProductBaxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546, Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information All lots received prior to 10/23/2002
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
FDA Determined
Cause 2
Other
ActionRecalled 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 Commerce0
DistributionNationwide, 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FPA
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