# FDA recall Z-0959-2021

> **Prytime Medical Devices, Inc.** · Class II · device recall initiated 2020-12-14.

## Product

PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C,    Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA  UDI: (01) 0 0863092 00010 1

## Reason for recall

There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.

## Distribution

US Nationwide distribution including in the states of NJ, NY, CA, TX, MI, MO, CO, MI, VA, DE, TN, MO, MT, AZ, FL, WI, SC, WA, TX, CT, IN, PA, ME, WI, MA, GA, OH, AR, UT, NY    OUS: None

## Key facts

- **Recall number:** Z-0959-2021
- **Recalling firm:** Prytime Medical Devices, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-14
- **Report date:** 2021-02-17
- **Termination date:** 2022-09-28

- **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-0959-2021

## Citation

> AI Analytics. FDA recall Z-0959-2021. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0959-2021. Source: US FDA. Licensed CC0.

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