medical Class II Updated 2019-08-07

Alto Development Corp recalls A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar P

Recalled Product

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.


Hazard / Issue

Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 0715A or later
View official government recall

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