Recall Z-1841-2021 ยท LRO General Surgery Tray
Medline Industries Inc
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.
| Date | Apr 30, 2021 |
| Status | Open, Classified |
| Reason | The devices may not meet the minimum required sterility assurance level. |
| Root cause | Software change control |
| Action | 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 |
| Quantity | 36/3-kit cases (108 kits) |
| Distribution | US Distribution to state of: WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.