LeMaitre Vascular, Inc.: Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood whe

Hazard

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Details from the source

Reason for recall: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. Distribution: No US distribution. International distribution to Great Britian and Switzerland. Quantity: 10 units Lot/code info: Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.

UPC codes

00316837000015, 00316837000022, 00316837000060, 00316837000084, 00316837000138

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.