Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product…
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)-YAMATO PLUS-R 7.5Fr 35cc
- IAB (Japan) Kit P/N0684-00-0560-01 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
300007950430000512113000051213300005121430000512153000051216300005121730000553143000056699300005731930000579683000058129300006263830000647263000068107300006810830000712863000072715300007271630000877453000090529300009066030000927763000076631300007775430000777553000080370300008037130000803723000080373300008037430000803753000080369300008333030000849633000084964300009277730000927783000095472300009637530000963773000096378300009875230000995883000099589
- Kit Lot Number
- Amount recalled
- 3542 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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