Recall Z-1745-2017
Covidien LLC · initiated March 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number beginning with: 14, 15, 16 *Exclude lots 16J098062 16J098162 16J098262 Expiration Date: From February 2017 through November 2019
Reason for recall
Product sterility is compromised due to breach of sterile barrier
FDA-determined 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.
Details
- Recall number
- Z-1745-2017
- Initiated
- March 3, 2017
- Posted by FDA
- March 27, 2017
- Terminated
- October 7, 2019
- Product code
- NAD – Dressing, Wound, Occlusive
- Quantity
- 1222080
- 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…
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1739-2017 Class II | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |
| Z-1740-2017 Class II | Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |
| Z-1741-2017 Class II | Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |
| Z-1742-2017 Class II | Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |
| Z-1743-2017 Class II | Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |
| Z-1744-2017 Class II | Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item…Product sterility is compromised due to breach of sterile barrier | 03/03/2017Terminated |