Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a
FDA device recall Z-1743-2017 · posted 2017-03-27 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Product sterility is compromised due to breach of sterile barrier
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NAD
- Quantity affected
- 38794
- Distribution
- Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece
- Date initiated
- 2017-03-03
- Date posted
- 2017-03-27
- Date terminated
- 2019-10-07
- Location
- North Haven, CT
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