FDA-Device2020-12-30Class II
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.
Prytime Medical Devices, Inc.
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.
Sold states
US Nationwide distribution in the state of Utah.
Affected count
3 units
Manufactured in
229 N Main St, N/A, Boerne, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2021Don't want to check this manually?
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