Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522

FDA device recall Z-1854-2016 · posted 2016-05-31 · Terminated

Recall details

Recalling firm

Covidien LLC

Reason for recall

Compromised sterility due to breach of barrier

Action taken

Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and 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. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878

Root cause

Packaging process control

Status

Terminated

Product code

LRS

Quantity affected

3152197

Distribution

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arab

Date initiated

2016-03-03

Date posted

2016-05-31

Date terminated

2017-06-15

Location

North Haven, CT