# FDA recall Z-1477-2021

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

## Product

Stopcock rotator (Component):  a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR  b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL  c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R.  Stopcocks and manifolds used to control the direction of IV fluid flow.

## 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-1477-2021
- **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-1477-2021

## Citation

> AI Analytics. FDA recall Z-1477-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1477-2021. Source: US FDA. Licensed CC0.

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