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U.S. Department of Health and Human Services

Class 2 Device Recall CheckFlo Performer Introducer Set

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 Class 2 Device Recall CheckFlo Performer Introducer Setsee related information
Date Initiated by FirmSeptember 16, 2024
Date PostedOctober 09, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0045-2025
Recall Event ID 95405
510(K)NumberK171999 
Product Classification Introducer, catheter - Product Code DYB
ProductCheck-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Code Information UDI-DI: 00827002272422; Lot Number: 15506769
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
Manufacturer Reason
for Recall		Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA Determined
Cause 2		Process control
ActionAn URGENT: MEDICAL DEVICE RECALL notification letter dated 9/13/24 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product s from the lot listed above. If so, quarantine any affected products that remain unused. Immediately cease all further distribution and use o f 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 and email the completed form to ausrecalls@cookmedical.com. 4. Please share this notice with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 1800 777 222 or by email at cau.complaints@cookmedical.com .
Quantity in Commerce50 units
DistributionInternational distribution to the country of Australia.
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.
510(K) Database510(K)s with Product Code = DYB
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