FDA Medical Device Recalls (openFDA)
Covidien LLC: VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
- Recall number
- Z-1599-2015
- Recalling firm
- Covidien LLC
- Product
- VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
- Status
- Terminated
- Initiated
- 2015-04-28
- Posted
- 2015-05-12
- Terminated
- 2016-03-29
- Reason
- Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
- Root cause
- Package design/selection
- Action
- Consignees were contacted by letter via email on April 28, 2015.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P140018"]
- Product code
- PJQ
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28