Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - 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)-TRANS-RAY PLUS 7.5Fr 40cc
- IAB (Japan) Kit P/N0684-00-0608 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
300004556830000479293000047928300004793030000533213000060109300006011030000676993000062192300006770030000677013000069728300006972930000697303000071288300007318730000762423000077669300007910530000793183000080309300008087630000842683000084967300008496030000849613000086800300008837230000905973000090598300009266830000926663000092667300009266930000962683000095468300009626730000962693000096270300009627130000965873000098175300009874730000987483000102410300010241130001034703000104519300010601130001077603000110622300011062330001127443000113154
- Kit Lot Number
- Amount recalled
- 11555 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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