Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias
Summary
The FDA issued a Class II for Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the i by Cook Biotech, Inc.. Reason: Products expire prior to the expiration date printed on the product labeling.
Details
Source
Device Recall
External ID
Z-3261-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Lot/Code Info: UDI: (01)10827002311418(17)250401(30)1\F1(10)LB1520598 (01)10827002311418(17)250314(30)1\F1(10)LB1522022 (01)10827002311418(17)250320(30)1\F1(10)LB1522024 (01)10827002311418(17)250320(30)1\F1(10)LB1523113 (01)10827002311418(17)250401(30)1\F1(10)LB1524938 (01)10827002311418(17)250320(30)1\F1(10)LB1525251 (01)10827002311418(17)250408(30)1\F1(10)LB1525812 (01)10827002311418(17)250416(30)1\F1(10)LB1525827 (01)10827002311418(17)250416(30)1\F1(10)LB1525839 (01)10827002311418(17)250416(30)1\F1(10)LB1525923 (01)10827002311418(17)250410(30)1\F1(10)LB1525956 (01)10827002311418(17)250426(30)1\F1(10)LB1527864 (01)10827002311418(17)250424(30)1\F1(10)LB1529682 Lot Number: LB1520598 LB1522022 LB1522024 LB1523113 LB1524938 LB1525251 LB1525812 LB1525827 LB1525839 LB1525923 LB1525956 LB1527864 LB1529682
Quantity Affected: 120 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-3261-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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