Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Summary
The FDA issued a Class II for Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for by Cook Biotech, Inc.. Reason: Products expire prior to the expiration date printed on the product labeling.
Details
Source
Device Recall
External ID
Z-3253-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
Lot/Code Info: UDI: (01)00827002546134(17) Lot Number: LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185
Quantity Affected: 93
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-3253-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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