Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01,…
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?
- Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc
- IAB Kit P/N
0684-00-0296-010684-00-0296-01U0684-00-0296-020684-00-0296-02U0684-00-0296-100684-00-0498-010684-00-0498-070684-00-0498-08
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
194 of 194 codes
300004641430000474313000048243300004908030000495693000050495300005115430000517513000053311300005459130000545923000056356300005662930000582773000060542300006424930000668003000065563300006796330000706683000071291300007197930000735163000074146300007599930000789213000080138300008013730000816243000082197300008284830000834303000084785300008699530000878883000089898300009175330000922393000092240300009445030000944513000095604300009697030000979573000100722300010506330001026283000105064300010710130001089623000109818300011278230000464153000047430300004824530000490853000049570300005115330000518813000053310
- Kit Lot Number
- Amount recalled
- 31529 WW
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Potential Endotoxin Contamination
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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