Recall Z-0716-2021— Prytime Medical Devices, Inc.
Class II · Terminated
Class II FDA medical device recall by Prytime Medical Devices, Inc., initiated 2020-10-29, terminated 2023-01-11. It names one FDA 510(k) clearance: K193440. 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: 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..
- Recalling firm
- Prytime Medical Devices, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-29
- Terminated
- 2023-01-11
- Firm location
- Boerne, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.