Z-1841-2021 Class II Ongoing
FDA device recall Z-1841-2021 was initiated by Medline Industries Inc on April 30, 2021 and is designated Class II. Reason for recall: The devices may not meet the minimum required sterility assurance level. The recall status is ongoing. Affected quantity: 36/3-kit cases (108 kits).
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36/3-kit cases (108 kits)
Product 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 for Recall
The devices may not meet the minimum required sterility assurance level.
Distribution Pattern
US Distribution to state of: WI.
Code Information
GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285