Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Reported: May 13, 2020 Initiated: March 10, 2020 #Z-1883-2020
Product Description
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Reason for Recall
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Details
- Recalling Firm
- Northgate Technologies, Inc.
- Units Affected
- 298 boxes. 3 units per box
- Distribution
- US Nationwide distribution. No governmental.
- Location
- Elgin, IL
Frequently Asked Questions
What product was recalled? ▼
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.. Recalled by Northgate Technologies, Inc.. Units affected: 298 boxes. 3 units per box.
Why was this product recalled? ▼
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1883-2020.
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