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Recall Observatory FDA recall evidence

Device product

MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

Z-2595-2023

August 03, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92881
Status
Ongoing
Classification
Class II
Quantity
324,451 devices
Official record key
device-enforcement:Z-2595-2023

Official wording

Reason: 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

Code information: UDI/DI 10080196847273, all lots

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.