Z-1119-2022 Class II Terminated
FDA device recall Z-1119-2022 was initiated by Steris Corporation on Mar 22, 2022 and is designated Class II. Reason for recall: Product not approved for release for US distribution The recall status is terminated (terminated Jan 29, 2024). Affected quantity: 152 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2022
- Initiation Date
- Mar 22, 2022
- Termination Date
- Jan 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152 cases
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
Distribution Pattern
Nationwide
Code Information
Lot Number: 202108
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1119-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026