Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - 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 35cc
- IAB (Japan) Kit P/N0684-00-0607 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
3000047804300005332230000533233000060107300006010830000622553000067698300006972730000719763000073186300007368030000736813000074885300007671030000767113000077752300007775330000791033000079104300008087330000808723000081671300008426730000849663000084965300008679930000885483000088371300009059930000906003000090601300009060230000906033000092664300009266330000926653000096263300009546730000962643000096265300009626630000981763000098177300010240830001024093000103469300010452030001046153000106012300010775830001077593000110626300011315530001122763000113156
- Kit Lot Number
- Amount recalled
- 12032 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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