Recall Z-1599-2015— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2015-04-28, terminated 2016-03-29. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-28
- Terminated
- 2016-03-29
- Firm location
- Mansfield, MA, United States
Product description
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Reason for recall
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Data sourced from openFDA. This site is unofficial and independent of the FDA.