Device product

Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602

Z-3259-2024

August 07, 2024

Class II

Product summary

Firm: Cook Biotech, Inc.
Event: Event 95149
Status: Ongoing
Classification: Class II
Quantity: 5 units
Official record key: device-enforcement:Z-3259-2024

Official wording

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

Code information: UDI: (01)00827002466029(17)250319(10)LB1524438 (01)00827002466029(17)250523(10)LB1533362 (01)00827002466029(17)250527(10)LB1534031 (01)00827002466029(17)250603(10)LB1534416 Lot Number: LB1524438 LB1533362 LB1534031 LB1534416

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