Home / Recalls / Prytime Medical Devices, Inc. / Z-0716-2021

Z-0716-2021 Class II Terminated

Recalled by Prytime Medical Devices, Inc. — Boerne, TX

Recall Details

Product Type: Devices
Report Date: December 30, 2020
Initiation Date: October 29, 2020
Termination Date: January 11, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 units

Product Description

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 Pattern

US Nationwide distribution in the state of Utah.

Code Information

Lot # 205936