Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal
Summary
The FDA issued a Class II for Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue f by Cook Biotech, Inc.. Reason: Products expire prior to the expiration date printed on the product labeling.
Details
Source
Device Recall
External ID
Z-3257-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
Lot/Code Info: UDI: (01)00827002463738(17)250319(10)LB1524437 (01)00827002463738(17)250319(10)LB1524441 (01)00827002463738(17)250319(10)LB1524453 (01)00827002463738(17)250402(10)LB1524456 (01)00827002463738(17)250319(10)LB1524457 (01)00827002463738(17)250402(10)LB1524484 (01)00827002463738(17)250408(10)LB1524495 (01)00827002463738(17)250402(10)LB1525243 (01)00827002463738(17)250416(10)LB1525244 (01)00827002463738(17)250402(10)LB1525249 (01)00827002463738(17)250416(10)LB1528983 (01)00827002463738(17)250416(10)LB1528999 (01)00827002463738(17)250416(10)LB1529377 (01)00827002463738(17)250626(10)LB1529380 (01)00827002463738(17)250429(10)LB1529383 (01)00827002463738(17)250419(10)LB1529680 (01)00827002463738(17)250429(10)LB1530192 (01)00827002463738(17)250429(10)LB1530299 (01)00827002463738(17)250429(10)LB1530308 (01)00827002463738(17)250520(10)LB1530309 (01)00827002463738(17)250523(10)LB1530310 (01)00827002463738(17)250531(10)LB1531363 (01)00827002463738(17)250531(10)LB1531404 (01)00827002463738(17)250531(10)LB1531406 (01)00827002463738(17)250603(10)LB1534887 (01)00827002463738(17)250626(10)LB1534888 Lot Number: LB1524437 LB1524441 LB1524453 LB1524456 LB1524457 LB1524484 LB1524495 LB1525243 LB1525244 LB1525249 LB1528983 LB1528999 LB1529377 LB1529380 LB1529383 LB1529680 LB1530192 LB1530299 LB1530308 LB1530309 LB1530310 LB1531363 LB1531404 LB1531406 LB1534887 LB1534888
Quantity Affected: 130 units
Reason for Recall
Products expire prior to the expiration date printed on the product labeling
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-07
Company
W Lafayette, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Biotech, Inc. has 15 FDA actions in our database, including 15 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Biotech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Biotech, Inc. have FDA actions?
Cook Biotech, Inc. has 15 FDA actions in our database, including 15 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3257-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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