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.
This recall has been terminated (originally issued March 27, 2017).
- Company
- Covidien Llc
- Recall Initiated
- March 3, 2017
- Posted
- March 27, 2017
- Terminated
- October 7, 2019
- Recall Number
- Z-1742-2017
- Quantity
- 104688
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility is compromised due to breach of sterile barrier
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.
Lot / Code Info
Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019
Root Cause
Packaging process control
Action Taken
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.