Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U,…
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)-Sensation 7Fr 40cc
- IAB Kit P/N
0684-00-0470-010684-00-0470-01U0684-00-0470-070684-00-0470-09 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
135 of 135 codes
300004631630000471613000047162300004861530000492623000049914300005092930000513803000052645300005409030000550993000056537300005994630000614473000062406300006598630000664893000066764300006677030000687303000069160300006937630000712933000071739300007319130000732773000074271300007513430000756763000076957300007965030000817783000084071300008478830000847893000086924300008529130000873683000088278300008857030000905263000090664300009244330000960523000097302300009899730001015223000103209300010682330001102123000111023300011211330000588953000064045300007319030000772043000084689300008616230000893493000094526
- Kit Lot Number
- Amount recalled
- 32855 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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