FDA Device recall Z-0682-2018
3-Way Standardbore Stopcock
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of 3-Way Standardbore Stopcock by Vygon Mfg Dba Churchill Medical Systems, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0682-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vygon Mfg Dba Churchill Medical Systems |
| Distribution | n/a |
Product
3-Way Standardbore Stopcock. Product Code: AMS-100.
Reason
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.
Identifiers
| code_info | Lot Number: 1706064D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0682-2018%22
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