# FDA recall Z-1476-2021

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2021-03-31.

## 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 for recall

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.

## Distribution

Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

## Key facts

- **Recall number:** Z-1476-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-31
- **Report date:** 2021-04-28
- **Termination date:** 2023-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2021

## Citation

> AI Analytics. FDA recall Z-1476-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1476-2021. Source: US FDA. Licensed CC0.

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