Prytime Medical Devices, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
MJN	—	—	—	3	2025-09-05

Date	Severity	Status	Recall #	Product	Code	Reason
2020-12-14	Class II	Terminated	Z-0959-2021	PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA,…	—	There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular …
2020-10-29	Class II	Terminated	Z-0716-2021	PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arter…	—	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…

Date	K-number	Device	Code	Class	Specialty
2025-09-05	K243795	pREBOA-PRO Catheter	MJN	—	—
2020-06-03	K200459	pREBOA-PRO Catheter	MJN	—	—
2020-01-09	K193440	ER-REBOA PLUS Catheter	MJN	—	—

Clearance cadence by quarter