FDA Device recall Z-2243-2021
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…
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of 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… by Merit Medical Systems, citing there is a potential that a package sheath contains an incorrect dilator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2243-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-21 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
There is a potential that a package sheath contains an incorrect dilator.
Identifiers
| code_info | Lot # H2069291 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2243-2021%22
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