Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 26, 2020
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devi
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Argon Medical Devices, Inc recalled ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; … - a moderate-severity action.
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; … was recalled by Argon Medical Devices, Inc in August 26, 2020. Reason: Sterile introducer sheath set manufactured under one lot with different expiration dates.. Check the official notice for the remedy. Verify recall #Z-2806-2020 with the FDA Devices before acting.
The recall
Argon Medical Devices, Inc issued this moderate-severity FDA Devices recall-Sterile introducer sheath set manufactured under one lot with different expiration dates..
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- August 26, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2806-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2806-2020) was formally reported on August 26, 2020, with the manufacturer initiating the action on June 19, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Argon Medical Devices, Inc is listed as the recalling firm, operating out of Athens, TX. Federal records list the affected scope as 1000 units.
The documented reason for this recall is: Sterile introducer sheath set manufactured under one lot with different expiration dates. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the state of MS.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1000 units
Related Recalls
6
3 from same agency
Product description
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reason for recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2806-2020 |
| Date reported | August 26, 2020 |
| Date initiated | June 19, 2020 |
| Recalling firm | Argon Medical Devices, Inc |
| Firm location | Athens, TX |
| Affected scope | 1000 units |
| Distribution | US Nationwide distribution including in the state of MS. |
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-2806-2020) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.. Recalled by Argon Medical Devices, Inc. Units affected: 1000 units.
Why was this product recalled? ▼
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2806-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the state of MS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2806-2020) 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 26, 2020. 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.