Skip to content
Recall Observatory FDA recall evidence

Device product

Clean Catch Kit, SKU DYKM1833A; Component No. 503581

Z-0354-2025

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-0354-2025

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: 40193489240697 (Case); 10193489240696 (Ea) Lots: 19LAA531 20BAA260 21KBJ974 22JBK243 22LBJ966 23BBU789 23FBN998 23HBW916 23IBH024 24CBE580 24DBT234 24GBA986 24GBL321

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.