Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C,…
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)-Linear 7.5Fr 25cc
- IAB Kit P/N
0684-00-0478-010684-00-0478-01C0684-00-0478-01U 0684-00-0478-020684-00-0478-02U -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
300004979730000535523000056193300005620130000577493000066195300006796530000698783000071222300007258530000742873000078937300007944630000805403000084470300009037230000925533000095910300009993030001036323000112148300005329730000571253000072586300004979830000535533000057748300006119330000662643000069270300007122130000725843000074288300007734130000778143000083060300008447130000874773000087478300008861930000903733000092552300009591130000999323000103631300005355430000565403000061194300006872830000925543000095912300009993330001022463000049800300007428930000925553000099931
- Kit Lot Number
- Amount recalled
- 1746 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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