Reported Nov 7, 2018 · Ongoing
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Maquet Datascope Corp. - Cardiac Assist Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Datascope Corp - Cardiac Assist Division · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
- Lot codes and dates
- UDI - 10607567108407 All Serial Numbers
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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