FDA-Device2016-06-08Class II
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
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
28085
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2016Don't want to check this manually?
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