MERITMEDICAL Prelude Short Sheath Introducer — Class II medical device recall Z-2243-2021
Terminated recall by Merit Medical Systems, Inc., reported 2021-08-18, distributed nationwide. There is a potential that a package sheath contains an incorrect dilator.
| Recall number | Z-2243-2021 |
|---|---|
| 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 | 2021-07-21 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CY, DE, ES, IT, KR, NL, SE, TW |
| Quantity | 373 units |
| UPC / GTIN / UDI-DI | 00884450015391 |
| Lot numbers | H2069291 |
| Model numbers | PSS-6F-4-018MT |
Product
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Reason for recall
There is a potential that a package sheath contains an incorrect dilator.
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-2243-2021. 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.