PlainRecalls
FDA Devices Moderate Class II Terminated

Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 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.

Reported: April 12, 2017 Initiated: March 3, 2017 #Z-1742-2017

Product Description

Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 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

Details

Recalling Firm
Covidien LLC
Units Affected
104688
Distribution
Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 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.. Recalled by Covidien LLC. Units affected: 104688.
Why was this product recalled?
Product sterility is compromised due to breach of sterile barrier
Which agency issued this recall?
This recall was issued by the FDA Devices on April 12, 2017. Severity: Moderate. Recall number: Z-1742-2017.