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Terminated

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

FDA Recall Z-1847-2016 · Posted 2016-05-31

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeLRS
Date Initiated2016-03-03
Date Terminated2017-06-15
Product Quantity713600

Reason for Recall

Compromised sterility due to breach of barrier

Firm Action

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

Distribution Pattern

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 Arabia, South Africa, Spain, Sweden and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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