Z-1549-2020 Class II Terminated
FDA device recall Z-1549-2020 was initiated by Carroll-Baccari, Inc. on December 23, 2019 and is designated Class II. Reason for recall: 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 reca… The recall status is terminated (terminated September 28, 2021). Affected quantity: 850 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- December 23, 2019
- Termination Date
- September 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 850 units
Product Description
PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
Reason for Recall
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.
Distribution Pattern
Nationwide, Canada, UK, Spain, Australia
Code Information
All Lots