Z-0793-2021 Class II Terminated
FDA device recall Z-0793-2021 was initiated by Steris Corporation on December 2, 2020 and is designated Class II. Reason for recall: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference … The recall status is terminated (terminated June 21, 2022). Affected quantity: 170 cases.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170 cases
Product Description
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Reason for Recall
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch
Distribution Pattern
Nationwide Foreign:
Code Information
Lot Number: 200428A, 200628A