Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U,…
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)-MEGA 7.5Fr 30cc IAB
- P/N
0684-00-0294-010684-00-0294-01U0684-00-0294-020684-00-0294-02U-
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
61 of 61 codes
300004704430000499103000055308300005927430000642523000067462300007122030000773433000084725300008685330000874753000087971300009671630000976473000100873300010211430001098163000047042300004793130000499133000055307300005643330000592753000060230300006240530000642513000067461300006785530000719813000071219300007198230000773423000080542300008108030000847243000086852300008797230000967153000090374300009255630000976463000102113300010614930001121513000114260300004704330000499113000064746300006746330000844733000097648300011215330000470413000047932300004991230000678563000071983300008747630000967933000097649
- Kit Lot Number
- Amount recalled
- 1275 kits 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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