Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use:…
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)-Trans-Ray 7Fr 40cc
- IAB (Japan) - Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Kit P/N0684-00-0546-01
- Lot codes and dates
- Kit Lot Number
3000051381300005331630000579693000062074300006698730000625573000062558300006698830000645243000066989300006699030000678903000069733300007439730000743983000077670300007767130000788573000080306300008031030000833343000083335300008427230000849693000087490300008749130000927793000092780300009547030000965863000098053300009805430000980553000098056300009959030000995913000112273300010776130001077623000112274
- Kit Lot Number
- Amount recalled
- 3059 Kits
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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