Date Initiated by Firm | January 20, 2016 |
Create Date | February 24, 2016 |
Recall Status1 |
Terminated 3 on November 21, 2016 |
Recall Number | Z-0865-2016 |
Recall Event ID |
73163 |
Product Classification |
Introducer, catheter - Product Code DYB
|
Product | Flexor 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
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For Additional Information Contact | Cook 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 |
Action | On 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 Commerce | 25 |
Distribution | Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY. |
Total Product Life Cycle | TPLC Device Report |
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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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