FDA Device recall Z-0093-2022
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX96…
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX96… by Smiths Medical Asd, citing reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0093-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-10 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Reason
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Identifiers
| code_info | All codes |
|---|
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-0093-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.