medical Class II Updated 2024-10-23

Merit Medical Systems, Inc. recalls MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

Recalled Product

MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B


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): IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027), H2925194(4/22/2027), H2929405(4/29/2027), H2934699(5/5/2027), H2937986(5/12/2027), H2943479(5/26/2027), H2978085(6/3/2027), H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027), H2925193(4/22/2027), H2929404(4/29/2027), H2934698(5/5/2027), H2937984(5/12/2027), H2943477(6/3/2027), H2972585(5/26/2027), H2982494(6/10/2027).
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