Safe N Simple, LLC
Clarkston, MI, US
SAFE N SIMPLE LLC appears in FDA device records in Clarkston, MI. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008374791 | 3008374791 | SAFE N SIMPLE LLC | 5827 Terex, Clarkston, MI 48346 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EZSAppliance, Colostomy, Disposable
- NECBandage, Liquid, Skin Protectant
- OJJBurn Kit Without Drug
- EZRCement, Stomal Appliance, Ostomy
- KMKDevice, Intravascular Catheter Securement
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- NABGauze / Sponge,Nonresorbable For External Use
- KOXSolvent, Adhesive Tape
- EXNSupport, Hernia
- KGXTape And Bandage, Adhesive
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0401-2019 | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345 | The sterilization process used was unqualified. | Class II | Terminated | |
| Z-0400-2019 | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 | The sterilization process used was unqualified. | Class II | Terminated | |
| Z-2229-2018 | DermaPro Waterproof Silicone Tape, SNS57232 | The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion. | Class II | Terminated | |
| Z-2330-2018 | Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain