FDA Device recall Z-0100-2022
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 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-0100-2022 |
| 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 CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
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-0100-2022%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.