# FDA recall Z-1472-2021

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

## Product

Left Heart Kit, Model Number M20268. for blood pressure monitoring.

## 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-1472-2021
- **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-1472-2021

## Citation

> AI Analytics. FDA recall Z-1472-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1472-2021. Source: US FDA. Licensed CC0.

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