# FDA recall Z-2160-2018

> **Maquet Cardiopulmonary Ag** · Class II · device recall initiated 2018-05-14.

## Product

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL,  Part Number 701002246, Article Number A22-7107.  For use in cardiopulmonary bypass

## Reason for recall

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

## Distribution

Worldwide distribution including US state of VA and Puerto Rico,  Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2160-2018
- **Recalling firm:** Maquet Cardiopulmonary Ag
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-14
- **Report date:** 2018-06-20
- **Termination date:** 2020-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rastatt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2018

## Citation

> AI Analytics. FDA recall Z-2160-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2160-2018. Source: US FDA. Licensed CC0.

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