Recall Z-0400-2019— Safe N Simple, LLC
Class II · Terminated
Class II FDA medical device recall by Safe N Simple, LLC, initiated 2018-08-22, terminated 2020-03-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315. Reason: The sterilization process used was unqualified..
- Recalling firm
- Safe N Simple, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-22
- Terminated
- 2020-03-17
- Firm location
- Clarkston, MI, United States
Product description
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Reason for recall
The sterilization process used was unqualified.
Data sourced from openFDA. This site is unofficial and independent of the FDA.