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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Medical

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 Class 2 Device Recall Cook Medicalsee related information
Date Initiated by FirmJuly 30, 2020
Create DateSeptember 15, 2020
Recall Status1 Terminated 3 on November 04, 2021
Recall NumberZ-2971-2020
Recall Event ID 86256
510(K)NumberK151051 K161236 
Product Classification Stent, ureteral - Product Code FAD
ProductCook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
Code Information Lot Number: 13060084
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
FDA Determined
Cause 2		Under Investigation by firm
ActionCook Medical notified William Cook Australia (WCA) on July 30, 2020. WCA notified customers on August 11, 2020. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. If affected products have already been placed within a patient, the indwell time should not exceed 180 days. 2. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 3. 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. Note: Unaffected products that are returned will not be credited. 4. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 5. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 6. 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 Commerce20 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FAD
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