FDA-Device2022-06-01Class II

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

Steris Corporation
Hazard

Product not approved for release for US distribution

Sold states
Nationwide
Affected count
103 cases
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2022

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