Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U,…
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 Balloon Catheters (IABs)-MEGA 7.5Fr 40cc
- IAB Kit P/N
0684-00-0295-010684-00-0295-01U0684-00-0295-020684-00-0295-02U0684-00-0295-050684-00-0295-070684-00-0295-090684-00-0295-10 -Product
- UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
156 of 156 codes
300004743330000487143000049793300005329630000545963000055303300005663130000602273000064257300007032130000718353000072581300007258230000769253000078405300007951830000801073000083511300008472130000876893000092131300009221530000957923000096364300009753430001008723000102116300010675030001076233000112279300004743230000479333000049794300005225530000553063000056632300006119730000642583000065635300006608630000662653000067264300006784130000686013000068602300007472930000748503000079519300008107930000805413000083512300008472230000874743000087973300008928230000921293000092130300009579330000976453000096762
- Kit Lot Number
- Amount recalled
- 16104 WW
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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