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FDA (Device enforcement)Recalled 2024-04-03class ii

Stryker Neurovascular: The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The cathete

Hazard

Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.

Details from the source

Reason for recall: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. Distribution: US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL. Quantity: 43 Lot/code info: UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025

UPC codes

07613327313895

Source

Official record: FDA (Device enforcement)

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

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