Device product
Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
Z-0368-2020
Product summary
- Event
- Event 83827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,979 units
- Official record key
device-enforcement:Z-0368-2020
Official wording
Reason: Product has the potential to be contaminated with Burholderia cepacia.
Code information: MD0019-T: 29824, 29901, 30006, 30145, 30236, 30352, 30675, 30729, 31138 MD0019-SUP: 29927, 30009, 30031, 30115, 30059, 30237, 30300, 30340, 30424, 30642, 30735, 31139
Distribution pattern: US, Canada, Spain, England, and Australia
Derived failure modes
-
Unknown
Product has the potential to be contaminated with Burholderia cepacia.