VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
FDA device recall Z-1599-2015 · posted 2015-05-12 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
- Action taken
- Consignees were contacted by letter via email on April 28, 2015.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- PJQ
- Quantity affected
- 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.
- Date initiated
- 2015-04-28
- Date posted
- 2015-05-12
- Date terminated
- 2016-03-29
- Location
- Mansfield, MA
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