FDA Enforcement
Class II
Ongoing
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Recall: Z-2024-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-2024-2024
- Event ID
- 94435
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 12, 2024
- Initiation Date
- April 30, 2024
- Classification Date
- June 6, 2024
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Reason
There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
Code Info
UDI/DI 10080196847273, Lot Numbers: 23GBV681, 23HBD138, 23IBF254, 23LBJ787
Distribution
Worldwide distribution - US Nationwide and the countries of Singapore, Canada.
Quantity
67811 units