FDA Enforcement
Class II
Ongoing
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Recall: Z-1841-2021
·
Reported June 16, 2021
Enforcement
- Recall Number
- Z-1841-2021
- Event ID
- 87910
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 16, 2021
- Initiation Date
- April 30, 2021
- Classification Date
- June 9, 2021
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Reason
The devices may not meet the minimum required sterility assurance level.
Code Info
GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285
Distribution
US Distribution to state of: WI.
Quantity
36/3-kit cases (108 kits)