FDAClass IIOctober 2, 2024

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To recall: Labeling Error

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

Why was Biodesign Inguinal Hernia Graft C-IHM-10X15 - To recalled?

Products expire prior to the expiration date printed on the product labeling

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Recalling firm
Cook Biotech, Inc.
Quantity
120 units
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.
Recall date
October 2, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls