Recall Z-1859-2016— Covidien LLC

Name: FDA recall Z-1859-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-03

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: Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321. 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

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

Reason for recall

Compromised sterility due to breach of barrier

Data sourced from openFDA. This site is unofficial and independent of the FDA.