# FDA recall Z-0155-2022

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2018-05-10.

## Product

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF):  a. 081-101BE  b. 081-101GE  c. 081-101GEE  d. 081-101NE  e. 081-102NE  f. 081-102RE  g. 089-101E  h. 888-101NE  i. 081-102GEE  j. 888-101BE  k. 888-101GE  l. 888-101GEE  m. 081-101RE  n. 081-102GE  o. 081-102BE  p. 888-101RE

## Reason for recall

Product has a lack of sterility assurance

## Distribution

International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.

## Key facts

- **Recall number:** Z-0155-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-10
- **Report date:** 2021-10-27
- **Termination date:** 2023-09-15

- **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-0155-2022

## Citation

> AI Analytics. FDA recall Z-0155-2022. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0155-2022. Source: US FDA. Licensed CC0.

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