FDA Device recall Z-1476-2021
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE,…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE,… by Smiths Medical Asd, citing specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1476-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-31 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.
Reason
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Identifiers
| code_info | a. Model Number MX1232MR, Lot Numbers: 4027757 b. Model Number MX1233MR, Lot Numbers: 4076456 c. Model Number MX132…a. Model Number MX1232MR, Lot Numbers: 4027757 b. Model Number MX1233MR, Lot Numbers: 4076456 c. Model Number MX1322MR, Lot Numbers: 3992363, 4011839 d. Model Number MX1333MR, Lot Numbers: 4016439 |
|---|
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-1476-2021%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.