Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C,…
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)-Sensation 7Fr 34cc IAB Kit
- P/N
0684-00-0469-010684-00-0469-01C0684-00-0469-01U0684-00-0469-070684-00-0469-09
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
100 of 100 codes
300004565730000471643000048708300004947730000509273000051753300005175430000527903000053815300005381630000564363000058893300005990630000632633000064521300006523330000666773000067689300007141330000723993000074269300007592230000778133000080874300008107830000830963000084472300008478730000868503000087366300008861830000899913000090768300009433730000973003000098247300009992930001029773000106755300011020830001111363000058894300007066530000731893000077203300008087530000846903000086792300008934830000943383000103213300011020930000456563000047710300004870930000494783000050926300005175230000527913000053817
- Kit Lot Number
- Amount recalled
- 13335 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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