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U.S. Department of Health and Human Services

Class 3 Device Recall Baxter Interlink System Huber Needle Extension Set

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 Class 3 Device Recall Baxter Interlink System Huber Needle Extension Setsee related information
Date Initiated by FirmMay 31, 2005
Date PostedJuly 28, 2005
Recall Status1 Terminated 3 on May 23, 2006
Recall NumberZ-1048-05
Recall Event ID 32191
510(K)NumberK961495 
Product Classification Set, Administration, Intravascular - Product Code FPA
ProductBaxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709
Code Information Lot FC04058
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		Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.
FDA Determined
Cause 2		Other
ActionBaxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837.
Quantity in Commerce4,850 sets
DistributionArkansas, Florida, Texas, North Carolina, Wisconsin and Japan.
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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