FDA Medical Device Recalls (openFDA)
Carroll-Baccari, Inc.: LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
- Recall number
- Z-1548-2020
- Recalling firm
- Carroll-Baccari, Inc.
- Product
- LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
- Status
- Terminated
- Initiated
- 2019-12-23
- Posted
- not on file
- Terminated
- 2021-09-28
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 8030 units
- Distribution
- Nationwide, Canada, UK, Spain, Australia
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KOY
- Firm FEI
- 3017189082
- Firm city
- Riviera Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28