PryTime Medical Recalls ER-Reboa Plus Catheters Due to Marking Errors
PryTime Medical is recalling 3 units of ER-Reoba Plus Catheters because they may have incorrect balloon and arterial line markings, which could delay procedures or injure patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient injury, but the source text does not report any actual injuries or hospitalizations, placing it in the 'High' severity category per the rubric.
Plain-English summary
PryTime Medical Devices, Inc. is recalling three units of the ER-Reoba Plus Catheter (Ref: ER7232PLUS, Lot # 205936). The recall was initiated because the catheters may have incorrectly marked balloons and arterial lines.
The incorrect markings could result in a delay to the medical procedure or cause injury to the patient. The affected products were distributed nationwide in the United States, specifically within the state of Utah.
Healthcare providers and consumers should stop using the affected catheters immediately. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- 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…
- Manufacturer
- Prytime Medical Devices, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 205936
Distribution
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