PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 1, 2022 Initiated: March 22, 2022 #Z-1118-2022

Product Description

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

Reason for Recall

Product not approved for release for US distribution

Details

Recalling Firm
Steris Corporation
Units Affected
103 cases
Distribution
Nationwide
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Steris Corporation. Units affected: 103 cases.
Why was this product recalled?
Product not approved for release for US distribution
Which agency issued this recall?
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1118-2022.