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U.S. Department of Health and Human Services

Class 2 Device Recall CXI Support Catheter

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 Class 2 Device Recall CXI Support Cathetersee related information
Date Initiated by FirmOctober 21, 2015
Date PostedNovember 06, 2015
Recall Status1 Terminated 3 on November 28, 2016
Recall NumberZ-0244-2016
Recall Event ID 72518
510(K)NumberK072724 
Product Classification Catheter, continuous flush - Product Code KRA
ProductCook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Code Information Catalog number:  CXI-2.6-18-90-P-NS-ANG Lot: 5505259 Expiration date: December 10, 2017  Catalog number: CXI-4.0-35-90-P-NS-0 Lots: 5505279 and 5505279X Expiration date: December 10, 2017
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Departme
800-457-4500
Manufacturer Reason
for Recall		Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.
FDA Determined
Cause 2		Labeling mix-ups
ActionCook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
Quantity in Commerce38
DistributionWorldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.
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 = KRA
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