Maquet Medical Systems USA: BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

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: 15,880 (US) Lot/code info: UDI-DI: 04058863019024 All lots

UPC codes

04058863019024

Source

Official record: FDA (Device enforcement) ↗

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