Z-3261-2024 Class II Ongoing

Recalled by Cook Biotech, Inc. — W Lafayette, IN

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
August 7, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 units

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

Reason for Recall

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

Distribution Pattern

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.

Code Information

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