FDA recall Z-0716-2021

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

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

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