Recall Z-1551-2020— Carroll-Baccari, Inc.
Class II · Terminated
Class II FDA medical device recall by Carroll-Baccari, Inc., initiated 2019-12-23, terminated 2021-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Wave Prep Tubes (1710-03) and single use cups (17--00-24). 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..
- Recalling firm
- Carroll-Baccari, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-23
- Terminated
- 2021-09-28
- Firm location
- Riviera Beach, FL, United States
Product description
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.