Angiodynamics, Inc.: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box),

Hazard

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Details from the source

Reason for recall: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand. Quantity: 515 units (103 boxes) Lot/code info: ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); UDI-DI: 25051684005712(Box), 15051684005715(Pouch); Lot No.: A2725033, A2725034, A3525048, A3525049;

UPC codes

25051684005712, 15051684005715

Source

Official record: FDA (Device enforcement) ↗

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