medical Class II Updated 2024-10-23

Merit Medical Systems, Inc. recalls DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152

Recalled Product

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A


Hazard / Issue

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI/Lot(Expiration): IN9135/A/00884450409640/H2918441(4/15/2027). IN9152/A/00884450409657/H2912682(4/8/2027)
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