Z-2595-2023 Class II Ongoing
FDA device recall Z-2595-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on August 3, 2023 and is designated Class II. 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 p… The recall status is ongoing. Affected quantity: 324,451 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 324,451 devices
Product Description
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 Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
Code Information
UDI/DI 10080196847273, all lots