Argyle UVC Insertion Tray containing Safety Scalpel N11 recall
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC)…
Why was Argyle UVC Insertion Tray containing Safety Scalpel N11 recalled?
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
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?
All lot codes
- Product
- Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC)…
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 7197 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 25, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)