Class II — Vygon U.S.A.
| Recalling firm | VYGON S A |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential friction holes may affect the sterility of the product. |
| Product | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system. |
| Quantity | 16520 total products |
| Distribution | Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA. |
| Initiated | 2018-02-28 |
| Classified | 2018-05-04 |
| Terminated | 2019-02-19 |
| Recall number | Z-1636-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vygon U.S.A. (Z-1636-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79752/
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