Class II — Vygon Corporation
| 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 | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. |
| Product | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. |
| Quantity | 210 |
| Distribution | Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania |
| Initiated | 2012-12-17 |
| Classified | 2013-03-11 |
| Terminated | 2014-01-14 |
| Recall number | Z-0937-2013 |
| 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 Corporation (Z-0937-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64458/
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