# FDA recall Z-0716-2021

> **Prytime Medical Devices, Inc.** · Class II · device recall initiated 2020-10-29.

## Product

PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

## Reason for recall

There is a potential that  catheters may have incorrectly marked balloon  and arterial lines.  This could result in a  procedure  delay or injury to the patient.

## Distribution

US Nationwide distribution in the state of Utah.

## Key facts

- **Recall number:** Z-0716-2021
- **Recalling firm:** Prytime Medical Devices, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-29
- **Report date:** 2020-12-30
- **Termination date:** 2023-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boerne, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2021

## Citation

> AI Analytics. FDA recall Z-0716-2021. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0716-2021. Source: US FDA. Licensed CC0.

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