Acmi 9fr Probe recall
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used…
Why was Acmi 9fr Probe recalled?
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 72-00198-0.
- Product
- ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used…
- Recalling firm
- Northgate Technologies, Inc.
- Quantity
- 1238 boxes. 3 units per box.
- Distribution
- US Nationwide distribution. No governmental.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)