CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
3-Way Standardbore Stopcock recalled by Vygon MFG, Inc
Vygon MFG Inc is recalling 3-Way Standardbore Stopcock. The recall was initiated on 24 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0682-2018
- FDA event ID
- 78951
- Recalling firm
- Vygon MFG Inc, Dover, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2017
- FDA classified
- 21 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 21 Feb 2018 | Classified by FDA | +212 days |
| 28 Feb 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
3-Way Standardbore Stopcock. Product Code: AMS-100.
Where it was distributed
U.S.
Questions about this recall
Why was it recalled?
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
Which lots are affected?
Lot Number: 1706064D
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 78951More recalls from Vygon MFG Inc
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Single Lumen CT Midline Basic Tray, Product recalled by Vygon MFG, Inc | Vygon MFG Inc | Other | TN |
| Device | CLASS II | Vygon IV Start Convenience Kits recalled by Vygon MFG, Inc | Vygon MFG Inc | Potency & Assay | NH |
| Device | CLASS II | x .75 LifeGuard Huber Needle with Y-site recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
| Device | CLASS II | Nutrisafe 2 Syringe for Safety Connection recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
| Device | CLASS II | CVC Tray Pediatrics recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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