Maquet Medical Systems USA: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823

Hazard

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Details from the source

Reason for recall: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia. Distribution: Domestic distribution nationwide. Quantity: 0 (US) Lot/code info: Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 All lots

UPC codes

4058863019147, 4058863017341

Source

Official record: FDA (Device enforcement) ↗

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