Reported Sep 14, 2022 · Ongoing
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Datascope Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Datascope Corporation · 15 Law Dr · Fairfield, NJ · 07004-3206
Is this the product you have?
- MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
- Lot codes and dates
Code information reads "UDI-DILot NoFinished Goods Part No.": 1060756710961930001844370684-00-0296-01U1060756710730130001715010684-00-0498-011060756710730130001833120684-00-0498-011060756710730130001833130684-00-0498-011060756710730130001866540684-00-0498-011060756710730130001866550684-00-0498-01
- Amount recalled
- 10,427 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Certain lots containing undersized dilator.
This product could cause temporary or reversible health problems — stop using it.
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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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