FDA-Device2016-06-08Class II

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Covidien LLC
Hazard

Compromised sterility due to breach of barrier

Sold states
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.
Affected count
350550
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2016

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