FDA Device recall Z-0512-2019
Medex High Pressure Stopcock used to control the direction of IV fluid flow
- FDA Device
- Class II
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of Medex High Pressure Stopcock used to control the direction of IV fluid flow by Smiths Medical Asd, citing certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0512-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-19 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
Reason
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
Identifiers
| code_info | Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0512-2019%22
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