FDAFDA · Food and drugs·Recall number Z-1641-2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Published June 7, 2023 · Recall initiated: May 18, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Medical Systems USA
- Distributor
- Domestic distribution nationwide.
- Lot
- Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.