Device product
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Z-1551-2020
Product summary
- Event
- Event 84587
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1444 units
- Official record key
device-enforcement:Z-1551-2020
Official wording
Reason: Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.
Code information: All Lots
Distribution pattern: Nationwide, Canada, UK, Spain, Australia
Derived failure modes
-
Microbial contamination
found to be contaminated with Burkholderia cepacia