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U.S. Department of Health and Human Services

Class 2 Device Recall Bentson Wire Guide (OUS ONLY)

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 Class 2 Device Recall Bentson Wire Guide (OUS ONLY)see related information
Date Initiated by FirmAugust 16, 2022
Date PostedSeptember 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1826-2022
Recall Event ID 90793
Product Classification Wire, guide, catheter - Product Code DQX
ProductBentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Code Information TSMB-35-145 (GPN G27041) UDI-DI 00827002270411, Lot 14797970, Expiration Date 16-06-2027
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in Commerce43 OUS
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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