FDA recall Z-2595-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-08-03
Report date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2595-2023