Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. The defect can delay critical neonatal treatment with potential for serious harm or death, though no illnesses or injuries have been reported to date.
Plain-English summary
Cardinal Health 200, LLC is recalling the Argyle UVC Insertion Tray (Product Code: 43201) containing a Safety Scalpel N11, used for inserting Umbilical Venous Catheters (UVC) into newborns. Approximately 7,197 units have been distributed nationwide to all lot codes.
The product lacks a specific Instructions for Use (IFU) for operating the Safety Scalpel N11. The scalpel features a permanent locking mechanism that, once engaged when the safety shield is closed and pushed forward, cannot be unlocked by the clinician.
This design defect can result in delays in treatment or therapy. In neonatal critical care, such delays could ultimately result in serious harm or death.
Healthcare facilities that have received this product should immediately discontinue use. Contact Cardinal Health 200, LLC for instructions on product return and information about appropriate alternative devices. Additional details are available through the FDA recall notice.
The recalled product
- Product
- 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 Code: 43201
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device
- Affected units
- 7,197
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
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