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Recall Observatory FDA recall evidence

Device 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.

Z-0716-2021

October 29, 2020

Class II

Product summary

Firm
Prytime Medical Devices, Inc.
Event
Event 86797
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0716-2021

Official wording

Reason: 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.

Code information: Lot # 205936

Distribution pattern: US Nationwide distribution in the state of Utah.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.