Maquet Medical Systems USA: HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

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: 8,670 (US) Lot/code info: UDI-DI: 04058863019000 All lots

UPC codes

04058863019000

Source

Official record: FDA (Device enforcement) ↗

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