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Open, Classified

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.

FDA Recall Z-1841-2021 · Posted None

Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2021-04-30
Product Quantity36/3-kit cases (108 kits)

Reason for Recall

The devices may not meet the minimum required sterility assurance level.

Firm 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 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.

Root Cause

Software change control

Distribution Pattern

US Distribution to state of: WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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