Skip to content
Recall Observatory FDA recall evidence

Device product

UA KIT, SKU DYKM1690A; Component No. 503581

Z-0356-2025

October 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95628
Status
Ongoing
Classification
Class II
Quantity
626,305 Total Kits (US only)
Official record key
device-enforcement:Z-0356-2025

Official wording

Reason: 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.

Code information: UDI-DI: 40193489744201 (Case); 10193489744200 (Ea) Lots: 19KAA457 19LAB178 20FAB341 20IAA286 20WBC414 21CBK056 21EBG180 21HBC490 21KBB192 22ABJ687 22DBO057 22GBO519 22IBB016 22LBC924 23BBN989 23EBF212 23GBA753 23IBD142 23LBJ724 24BBI191 24FBC575 24GBX259

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.