United StatesArtegraft Collagen Vascular Graft (models AG630M, AG636M, AG730M, AG740M, AG845M; UDI‑DIs 00316837000015, 00316837000022, 00316837000060, 00316837000084, 00316837000138; exp. 28 Jul 2027) used as a substitute vascular conduit is affected. The devices were recalled because they were distributed with incorrect labeling missing the CE and UKCA marks and missing the patient leaflet and patient implant card. These units were distributed internationally to Great Britain and Switzerland (no US distribution).
What's being recalled
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 where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Recalling firm: LeMaitre Vascular, Inc., North Brunswick, NJ, United States.
How to identify it
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.
The hazard
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
No US distribution. International distribution to Great Britian and Switzerland.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)