FDA-Device2022-06-01Class II

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

Steris Corporation
Hazard

Product not approved for release for US distribution

Sold states
Nationwide
Affected count
152 cases
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2022

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