Custom Sheath Introducer Kit REF K21-00031 — Class II medical device recall Z-1956-2020
Terminated recall by Merit Medical Systems, Inc., reported 2020-05-20, distributed nationwide. labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheat
| Recall number | Z-1956-2020 |
|---|---|
| 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 | 2019-09-12 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450426357 |
| Lot numbers | H1583914 |
| Model numbers | K21-00031 |
Product
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Reason for recall
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
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-1956-2020. 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.