Home / Recalls / Medical Devices
Maquet Medical Systems USA recalls BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Recalled June 7, 2023 · FDA recall Z-1635-2023 · Maquet Medical Systems USA
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. · FDA Class II
Units
15,880 (US)
Sold at
Domestic distribution nationwide.
Description
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.
Product
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →