Reported Sep 2, 2020 · Ongoing
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C,…
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 34cc
- IAB Kit P/N
0684-00-0479-010684-00-0479-01C0684-00-0479-01U0684-00-0479-020684-00-0479-02U0684-00-0479-070684-00-0479-080684-00-0479-10 -
- Product UsageIndications
- For UseAcute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure
- Lot codes and dates
- Kit Lot Number
259 of 259 codes
300004763530000487123000048711300004931130000512963000052326300005363430000548213000056194300005720430000584173000059272300005927330000614483000062934300006513330000657243000066487300006813530000698773000071129300007189030000735193000074021300007591730000769553000079930300007781130000790553000079517300008067330000822533000083197300008406830000848523000084853300008575630000869253000088673300008961030000913203000091698300009389530000967393000100472300010193430001057343000106532300010653330001094493000113519300011678030000473543000047707300004802730000489633000050259300005164530000516463000052792
- Kit Lot Number
- Amount recalled
- 54816 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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