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Recall Observatory FDA recall evidence

Device product

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

Z-3261-2024

August 07, 2024

Class II

Product summary

Firm
Cook Biotech, Inc.
Event
Event 95149
Status
Ongoing
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-3261-2024

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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