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
- Recall Number
- Z-1841-2021
- Event Number
- 87910
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- LRO
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- April 30, 2021
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
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.
The devices may not meet the minimum required sterility assurance level.
The recalling firm, Medline Industries, Inc., issued an "IMMEDIATE ACTION REQUIRED RECALL" letter dated and emailed on 4/30/2021. The letter described the product, the reason for recall and actions to be taken. The consignees were instructed to immediately check their inventory for the affected product, complete and submit response form online to: Website link: https://recalls.medline.com; Recall Reference #: R-21-073; Recall Code: R5A2C566 , and quarantine it for subsequent return. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact the Recall Department at 866-359-1704.
US Distribution to state of: WI.
36/3-kit cases (108 kits)