Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 25, 2021
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardinal Health 200, LLC recalled Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). In… - a critical-severity action.
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). In… was recalled by Cardinal Health 200, LLC in August 25, 2021. Reason: The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The …. Check the official notice for the remedy. Verify recall #Z-2244-2021 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this critical-severity FDA Devices recall-The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The ….
- Critical
- severity level
- 7K units
- affected scope
- Class I
- classification
- August 25, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2244-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2244-2021) was formally reported on August 25, 2021, with the manufacturer initiating the action on June 16, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 7197 units.
The documented reason for this recall is: 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 scalpe… Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7197 units
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2244-2021 |
| Date reported | August 25, 2021 |
| Date initiated | June 16, 2021 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Mansfield, MA |
| Affected scope | 7197 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2244-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health 200, LLC. Units affected: 7197 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Critical. Recall number: Z-2244-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2244-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 25, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.