ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - P
FDA device recall Z-1885-2020 · posted 2020-03-24 · Terminated
Recall details
- Recalling firm
- Northgate Technologies, Inc.
- Reason for recall
- Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- Action taken
- Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 1238 boxes. 3 units per box.
- Distribution
- US Nationwide distribution. No governmental.
- Date initiated
- 2020-03-10
- Date posted
- 2020-03-24
- Date terminated
- 2021-02-02
- Location
- Elgin, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K914516) | Northgate Technologies, Inc. | 1992-01-07 |