Recall Z-1847-2016— 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: Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.. 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
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
Reason for recall
Compromised sterility due to breach of barrier
Data sourced from openFDA. This site is unofficial and independent of the FDA.