Reported Aug 25, 2021 · Terminated
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an…
Cardinal Health 200, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 15 Hampshire St Bldg 5 · Mansfield, MA · 02048-1113
Is this the product you have?
- Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate
- Product Code43201
- Lot codes and dates
- All lot codes
- Amount recalled
- 7197 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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