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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Medical CheckFlo

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 Class 2 Device Recall Cook Medical CheckFlosee related information
Date Initiated by FirmApril 17, 2025
Date PostedMay 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1787-2025
Recall Event ID 96703
Product Classification Introducer, catheter - Product Code DYB
ProductCheck=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Code Information UDI/DI 00827002089570, Lot Number 16376242
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
FDA Determined
Cause 2		Under Investigation by firm
ActionCook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 04/17/2025 via FedEx Standard Overnight. The notice explained the issue, potential risk to health and requested: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.
Quantity in Commerce89 units
DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
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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