Certified Safety Mfg., Inc.
Country not established FDA establishment FEI 1000158435
- Devices
- 17
- Registrations
- FDA
- FDA recalls
- 3
What Certified Safety Mfg., Inc. makes
Certified Safety Mfg., Inc. manufactures wound care and trauma dressings, including specialized burn/trauma face dressings and towel dressings, multi-function trauma dressings, gauze compresses, bandage compresses (2-, 3-, and 4-inch), triangular bandages, and roll bandages in various sizes. Their portfolio also includes trauma pads, first aid/trauma kits, and protective dressings like the CPROTECTOR and CPROTECTOR 2000.
The company’s products are regulated under FDA device classes I, II, N, and U, with many listed via the 510(k) pathway. These items are intended for wound protection, trauma management, and first aid applications. The manufacturer is based in the United States.
Catalogue
Search and filter all 17 devicesCompany details
- FDA FEI number
- 1000158435
- Address
- 1400 Chestnut Ave, KANSAS CITY, MO, 64127
FDA recalls
FDA recall records list 3 recalls initiated by CERTIFIED SAFETY MFG., INC., the earliest on 2017-06-26 and the most recent on 2022-04-05. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 5 Apr 2022 Z-1060-2022 Class II Terminated First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
Full distribution text
- 5 Apr 2022 Z-1060-2022 Class II Terminated First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
2018
- 20 Mar 2018 Z-1353-2018 Class II Terminated Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
Full distribution text
- 20 Mar 2018 Z-1353-2018 Class II Terminated Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
2017
- 26 Jun 2017 Z-3078-2017 Class II Terminated Burn Sheet has possibility of being shredded.
Frequently asked questions
How many devices does CERTIFIED SAFETY MFG., INC. have in the registry?
The registry currently lists 17 devices for CERTIFIED SAFETY MFG., INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CERTIFIED SAFETY MFG., INC.'s devices?
Among its 17 most recently registered devices, CERTIFIED SAFETY MFG., INC. has devices listed in FDA 510(k) (17 devices).
What risk classes do CERTIFIED SAFETY MFG., INC.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for CERTIFIED SAFETY MFG., INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CERTIFIED SAFETY MFG., INC.?
FDA recall records list 3 recalls initiated by CERTIFIED SAFETY MFG., INC., the most recent initiated on 2022-04-05. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CERTIFIED SAFETY MFG., INC. in the registry?
The most recently registered devices listed for CERTIFIED SAFETY MFG., INC. include CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING, X-LARGE MULTI-FUNCTION TRAUMA DRESSING, GAUZE COMPRESS and 2, 3 & 4 BANDADGE COMPRESS.