Z-0401-2019 Class II Terminated
FDA device recall Z-0401-2019 was initiated by Safe N Simple, LLC on August 22, 2018 and is designated Class II. Reason for recall: The sterilization process used was unqualified. The recall status is terminated (terminated March 17, 2020). Affected quantity: 125 cases.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- August 22, 2018
- Termination Date
- March 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 cases
Product Description
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Reason for Recall
The sterilization process used was unqualified.
Distribution Pattern
CA
Code Information
lot number 18060564