—#187414

Product

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 product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285

Why it was recalled

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

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Distribution to state of: WI.

Timeline

Recall initiated: 2021-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.