Probe, 9 FR Autolith recall
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Why was Probe, 9 FR Autolith recalled?
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
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?
NTI Catalog Number 9-900-54.
- Product
- Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Recalling firm
- Northgate Technologies, Inc.
- Quantity
- 298 boxes. 3 units per box
- Distribution
- US Nationwide distribution. No governmental.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)