Device product
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
Z-0369-2020
Product summary
- Event
- Event 83827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2445 units
- Official record key
device-enforcement:Z-0369-2020
Official wording
Reason: Product has the potential to be contaminated with Burholderia cepacia.
Code information: MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711
Distribution pattern: US, Canada, Spain, England, and Australia
Derived failure modes
-
Unknown
Product has the potential to be contaminated with Burholderia cepacia.