Device 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
Z-1744-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168824
- Official record key
device-enforcement:Z-1744-2017
Official wording
Reason: Product sterility is compromised due to breach of sterile barrier
Code information: Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
sterility is compromised