Home / Recalls / Medical Devices
Prytime Medical Devices, Inc. recalls PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arter
Recalled December 30, 2020 · FDA recall Z-0716-2021 · Prytime Medical Devices
Hazard
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. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the state of Utah.
Description
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.
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.
Manufacturer(s)
Prytime Medical Devices, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →