Prytime Medical Devices, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0716-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 29, 2020

Date Posted: December 30, 2020

Recall Number: Z-0716-2021

Event ID: 86797

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

Lot # 205936

Distribution Pattern:

US Nationwide distribution in the state of Utah.

Voluntary or Mandated:

Voluntary: Firm initiated