# FDA recall Z-2059-2019

> **Zyno Medical LLC** · Class II · device recall initiated 2019-05-29.

## Product

Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed    Product Code: B2-70072-F

## Reason for recall

Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of  delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch  clamp is not identified

## Distribution

MA

## Key facts

- **Recall number:** Z-2059-2019
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-29
- **Report date:** 2019-07-31
- **Termination date:** 2020-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Natick, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2019

## Citation

> AI Analytics. FDA recall Z-2059-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2059-2019. Source: US FDA. Licensed CC0.

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