Recall Z-1848-2016— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2016-03-03, terminated 2017-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034. Reason: Compromised sterility due to breach of barrier.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-03
- Terminated
- 2017-06-15
- Firm location
- North Haven, CT, United States
Product description
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
Reason for recall
Compromised sterility due to breach of barrier
Data sourced from openFDA. This site is unofficial and independent of the FDA.