FDA Medical Device Recalls (openFDA)
Carroll-Baccari, Inc.: Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
- Recall number
- Z-0368-2020
- Recalling firm
- Carroll-Baccari, Inc.
- Product
- Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
- Status
- Terminated
- Initiated
- 2019-09-05
- Posted
- not on file
- Terminated
- 2021-10-19
- Reason
- Product has the potential to be contaminated with Burholderia cepacia.
- Root cause
- Material/Component Contamination
- Action
- The firm initiated the recall of Lemon Prep by email on 09/05/2019. Distributors were directed to notify their customers and ask them to contact Mavidon directly. Direct accounts were asked to cease use and contact the company for replacement. The firm issued a press release on 09/30/2019 and posted a copy along with a copy of the recall notice on their website. The firm initiated the recall of its Pedia Prep on 10/08/2019 by email and posted a copy of the recall letter on its website.
- Quantity
- 24,979 units
- Distribution
- US, Canada, Spain, England, and Australia
- Lot, serial or model codes
- MD0019-T: 29824, 29901, 30006, 30145, 30236, 30352, 30675, 30729, 31138 MD0019-SUP: 29927, 30009, 30031, 30115, 30059, 30237, 30300, 30340, 30424, 30642, 30735, 31139
- 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