Recall Z-1744-2017— Covidien LLC

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2017-03-03, terminated 2019-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds. Reason: Product sterility is compromised due to breach of sterile barrier.

Recalling firm
Covidien LLC
Classification
Class II
Status
Terminated
Initiated
2017-03-03
Terminated
2019-10-07
Firm location
North Haven, CT, United States

Product description

Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds

Reason for recall

Product sterility is compromised due to breach of sterile barrier

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