Recall Z-1119-2022— Steris Corporation

Name: FDA recall Z-1119-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-22

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2022-03-22, terminated 2024-01-29. It names one FDA 510(k) clearance: K984187. Product: 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. Reason: Product not approved for release for US distribution.

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2022-03-22
Terminated: 2024-01-29
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K984187 — CROSSTEX NON-WOVEN SPONGESCrosstex Intl.·cleared 1999-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product not approved for release for US distribution

Data sourced from openFDA. This site is unofficial and independent of the FDA.