FDA Enforcement
Class II
Terminated
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Recall: Z-0400-2019
·
Reported November 14, 2018
Enforcement
- Recall Number
- Z-0400-2019
- Event ID
- 81150
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Safe N Simple, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2018
- Initiation Date
- August 22, 2018
- Classification Date
- November 7, 2018
- Termination Date
- March 17, 2020
- Address
- 5827 Terex, Clarkston, MI, 48346-1717, United States
Description
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Reason
The sterilization process used was unqualified.
Code Info
lot number 18060563
Distribution
CA
Quantity
104 cases