Tripolar Hooked Stimulation Probes recall
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Why was Tripolar Hooked Stimulation Probes 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 SI20F2956I
- Product
- Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
- Recalling firm
- Spes Medica
- Quantity
- 3 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)