Class II — Covidien LLC
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray. |
| Product | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. |
| Quantity | 1661 units |
| Distribution | Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom. |
| Initiated | 2015-04-28 |
| Classified | 2015-05-12 |
| Terminated | 2016-03-29 |
| Recall number | Z-1599-2015 |
| 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 — Covidien LLC (Z-1599-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71138/
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