Custom Procedure Kit — Class II medical device recall Z-0027-2020
Terminated recall by Merit Medical Systems, Inc., reported 2019-10-09, distributed in IL, VA. Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.
| Recall number | Z-0027-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2018-10-26 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-06-12 |
| Distributed | IL, VA |
| Quantity | 24 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450390580 |
| Lot numbers | K12T-10167 |
| Model numbers | K12T-10167 |
| Expiration dates | 2018-11-05 |
Product
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Reason for recall
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0027-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.