Atlas FDA

Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various material

FDA device recall Z-1739-2017 · 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
HMP
Quantity affected
7168000
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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