FDAClass IIJuly 7, 2021

SNS Disposable Urethral Catheter Electrode recall

SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter…

Why was SNS Disposable Urethral Catheter Electrode recalled?

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

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 UR20F2702I

Product
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter…
Recalling firm
Spes Medica
Quantity
34 boxes
Distribution
Distribution in the following US states: CA, MA, and SC.
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls