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 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.


Hazard / Issue

Potential Endotoxin Contamination

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Kit Lot Number: 3000066986 3000069732 3000077731 3000077732 3000080305 3000083332 3000083333 3000084968 3000087492 3000095469 3000096180 3000096181 3000096585 3000098052 3000103498 3000104616 3000104617 3000112275 3000113067
View official government recall

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