PryTime Medical - ER-Reboa Plus Catheter recall
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0…
Why was PryTime Medical - ER-Reboa Plus Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 205936
- Product
- PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0…
- Recalling firm
- Prytime Medical Devices, Inc.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the state of Utah.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)