—#210828

Product

Lab Kit, SKU DYLAB1018; Component No. 503581

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246

Why it was recalled

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On October 23, 2024, the firm notified customers via Medical Device Recall letters sent through First Class Mail and Email. Customers were informed that the product is actually non-sterile and provided with the full list of impacted convenience kits. Once customers submit the recall response form, they will receive an over-label to place on affected kits, which instruct the user to remove the recalled component. Customers who would like a replacement specimen container may contact their sales representative. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

Timeline

Recall initiated: 2024-10-23
Posted by FDA: 2024-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.