Recall Z-1745-2017— 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 Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.. 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 Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
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.