medical Class II Updated 2020-09-02

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr

Recalled Product

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01


Hazard / Issue

Potential Endotoxin Contamination

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Kit Lot Number: 3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274
View official government recall

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