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U.S. Department of Health and Human Services

Class 2 Device Recall Flexor CheckFlo Introducer

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 Class 2 Device Recall Flexor CheckFlo Introducersee related information
Date Initiated by FirmJanuary 20, 2016
Create DateFebruary 24, 2016
Recall Status1 Terminated 3 on November 21, 2016
Recall NumberZ-0865-2016
Recall Event ID 73163
Product Classification Introducer, catheter - Product Code DYB
ProductFlexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Code Information Catalog #:  KCFW-6.0-35-70-RB-HFANL0-HC  Lot: 6166304
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		Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee 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 (800) 457-4500 or 1(812) 339-2235.
Quantity in Commerce25
DistributionDistributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
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.
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