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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System Straight Type Blood Set

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 Class 2 Device Recall Baxter Interlink System Straight Type Blood Setsee related information
Date Initiated by FirmDecember 06, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on November 01, 2012
Recall NumberZ-0481-2012
Recall Event ID 60608
510(K)NumberK932301 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBaxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 4C6832 Intended use: for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets
Code Information product code 4C6832, lot number GR296319
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact
800-422-9837
Manufacturer Reason
for Recall
During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.
FDA Determined
Cause 2
Employee error
ActionThe firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to fca@baxter.com; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall. If you have any questions regarding the communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in Commerce528 units
DistributionWorldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.
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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