ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Company
- Northgate Technologies, Inc.
- Recall Initiated
- March 10, 2020
- Posted
- March 24, 2020
- Terminated
- February 2, 2021
- Recall Number
- Z-1885-2020
- Quantity
- 1238 boxes. 3 units per box.
- Firm Location
- Elgin, IL
Reason for Recall
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Distribution
US Nationwide distribution. No governmental.
Lot / Code Info
NTI Catalog Number 72-00198-0.
Root Cause
Nonconforming Material/Component
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".
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