Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - 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)-YAMATO PLUS-R 7.5Fr 30cc
- IAB (Japan) Kit P/N0684-00-0559-01 -
- 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
300004534930000512183000053318300005530930000553103000055311300005670330000573163000057317300005796730000662133000066214300006810930000681103000068111300006973130000714123000072401300007240230000736823000073816300007381730000748873000083328300008332930000877463000076462300007885530000793193000079320300008332630000803083000083327300008774730000905303000090531300009277330000963673000096368300009547130000963693000096370300009637130000963723000096373300009637430000987493000098750300010350330001035043000103505300010350630001105803000110581300011058230001105833000110584300011300830001130093000113148
- Kit Lot Number
- Amount recalled
- 6111 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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