FDAFDA · Food and drugs·Recall number Z-0100-2019
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Published November 7, 2018 · Recall initiated: September 20, 2018
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
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Distributor
- US Nationwide; Internationally to 77 countries
- Lot
- UDI - 10607567108407 All Serial Numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.