FDA Device recall Z-1599-2015
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402 by Covidien, citing possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1599-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-28 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | n/a |
Product
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Reason
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Identifiers
| code_info | Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 3875…Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1599-2015%22
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