Clarkston, MI, United States
Safe N Simple, LLC recalls
3 recalls recorded since 2018, most recently on 22 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 August 2018
- Terminated
- 17 March 2020
- Reason
- The sterilization process used was unqualified.
- Distribution
- CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0401-2019, Z-0400-2019
- Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
- Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Terminated Class II Medical devices
- Recall started
- 14 December 2017
- Terminated
- 4 April 2019
- Reason
- The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
- Distribution
- Distributors in two states: AL and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2229-2018
- DermaPro Waterproof Silicone Tape, SNS57232
Terminated Class II Medical devices
- Recall started
- 18 June 2012
- Terminated
- 28 May 2020
- Reason
- The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.
- Distribution
- Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2330-2018
- Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.