Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - 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 40cc
- IAB (Japan) Kit P/N0684-00-0561-01 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
300005331730000566943000057318300005797030000620733000062639300006264030000681063000071287300007271730000647233000072718300007271930000748863000087744300009052830000766323000078856300008030730000833313000084962300009277430000927753000095473300009637630000966063000096379300009875130001045213000115011
- Kit Lot Number
- Amount recalled
- 3055 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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