Bio-Detek, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Bio-Detek, Inc. makes
Bio-Detek, Inc. manufactures multi-function electrodes for adult and pediatric patients, including defibrillation electrodes, ECG electrodes, EEG electrodes, and CPR-related electrodes such as OneStep Pediatric CPR Multi-Function Electrode and POCKETCPR. The company also produces reusable defibrillation electrodes with hydrogel gel, radio translucent devices, and electrosurgical ground pads.
The devices are classified as Class II and Class III medical devices and are listed in the FDA 510(k) registry. Bio-Detek, Inc. is based in the United States.
Catalogue
Search and filter all 17 devicesFDA recalls
FDA recall records list 12 recalls initiated by Bio-Detek, Inc., the earliest on 2004-07-30 and the most recent on 2019-05-28. By recorded status: 12 terminated. The reasons filed fall into these groups: sterility or contamination, packaging 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 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 28 May 2019 Z-1945-2019 Class II Terminated Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Full distribution text
- 28 May 2019 Z-1945-2019 Class II Terminated Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
2014
- 16 Sep 2014 Z-0052-2015 Class II Terminated Product sterility is not assured
- 16 Sep 2014 Z-0053-2015 Class II Terminated Product sterility is not assured
- 16 Sep 2014 Z-0054-2015 Class II Terminated Product sterility is not assured
- 16 Sep 2014 Z-0055-2015 Class II Terminated Product sterility is not assured
- 26 Aug 2014 Z-2658-2014 Class II Terminated Sterility of device is not assured
- 26 Aug 2014 Z-2659-2014 Class II Terminated Sterility of device is not assured
- 26 Aug 2014 Z-2660-2014 Class II Terminated Sterility of device is not assured
2013
- 12 Mar 2013 Z-2565-2014 Class II Terminated Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
2011
- 30 Dec 2011 Z-1011-2012 Unclassified (pre-2012) Terminated Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
Show all 12 recalls
2008
- 16 Jun 2008 Z-2334-2008 Unclassified (pre-2012) Terminated Multi-function electrode programmed as a Pediatric instead of Adult
2004
- 30 Jul 2004 Z-1380-04 Unclassified (pre-2012) Terminated Pads may fail due to excessive corrosion of the electrode prior to the expiration date
Frequently asked questions
How many devices does Bio-Detek, Inc. have in the registry?
The registry currently lists 17 devices for Bio-Detek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Detek, Inc.'s devices?
Among its 17 most recently registered devices, Bio-Detek, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Bio-Detek, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Bio-Detek, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Bio-Detek, Inc.?
FDA recall records list 12 recalls initiated by Bio-Detek, Inc., the most recent initiated on 28 May 2019. 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 Bio-Detek, Inc. in the registry?
The most recently registered devices listed for Bio-Detek, Inc. include BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR, RT40 RADIO TRANSLUCENT, ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES and ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003.