Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PryTime Medical - ER-Reboa Plus Catheter Recalled by Prytime Medical Devices, Inc. Due to There is a potential that catheters may have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Prytime Medical Devices, Inc. directly.
Affected 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.
Quantity: 3 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report