UA KIT, SKU DYKM1690A; Component No. 503581

FDA device recall Z-0356-2025 · posted 2024-11-12 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRO

Quantity affected

626,305 Total Kits (US only)

Distribution

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

Date initiated

2024-10-23

Date posted

2024-11-12

Location

Northfield, IL