Z-3013-2020 Class II Terminated
FDA device recall Z-3013-2020 was initiated by Medline Industries Inc on August 12, 2020 and is designated Class II. Reason for recall: Potential of incomplete seals impacting the sterility of the kit. The recall status is terminated (terminated April 28, 2021). Affected quantity: 60 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 12, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 kits
Product Description
Central Line Dressing Change Tray
Reason for Recall
Potential of incomplete seals impacting the sterility of the kit.
Distribution Pattern
Domestic Distribution: MN and TX.
Code Information
Lot Number: 2020021990 Product Numbers: DYNDC1928C