Carroll-Baccari, Inc. Wave Prep Tubes (1710-03) and single use cups (17--00-24) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Brand
Carroll-Baccari, Inc.
Lot Codes / Batch Numbers
All Lots
Products Sold
All Lots
Carroll-Baccari, Inc. is recalling Wave Prep Tubes (1710-03) and single use cups (17--00-24) due to 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 conta. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by issuing a public notice on 12/24/2019 then followed with recall letters on 12/26/2019. The firm followed with an amended recall notice disseminated on 01/07/2020, which removed the Collodion products, removers, and acetone. The letters requested the following actions: "1. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it. 2. Fill out the Medical Device Recall form below and email it to CS@mavidon.com 3. We will follow up and give instructions on how to return the product for credit." Contact Mavidon at 800-654-0385 or by email to CS@mavidon.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026