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U.S. Department of Health and Human Services

Class 2 Device Recall Biodesign Fistula Plug

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 Class 2 Device Recall Biodesign Fistula Plugsee related information
Date Initiated by FirmAugust 07, 2024
Date PostedSeptember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3255-2024
Recall Event ID 95149
510(K)NumberK062729 
Product Classification Mesh, surgical - Product Code FTM
ProductBiodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Code Information UDI: (01)00827002463745(17)250319(10)LB1524446 Lot Number: LB1524446
Recalling Firm/
Manufacturer		 Cook Biotech, Inc.
1425 Innovation Pl
W Lafayette IN 47906-1000
For Additional Information ContactSAME
765-497-3355
Manufacturer Reason
for Recall		Products expire prior to the expiration date printed on the product labeling
FDA Determined
Cause 2		Incorrect or no expiration date
ActionCook Biotech Inc. issued Urgent: Medical Device Recall Letter on 8/7/24. Letter states reason for recall, health risk and action to take: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of Biodesign Fistula Plugs with Lot Numbers provided in the Product Information section of this letter. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Note: Unaffected products that are returned will not be credited. 3. 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). 4. 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. 5. 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. Cook Biotech initiated CAPA 2024-CR-002 for this issue. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in Commerce5 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.
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 = FTM
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