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U.S. Department of Health and Human Services

Class 2 Device Recall Lemon Prep

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  Class 2 Device Recall Lemon Prep see related information
Date Initiated by Firm September 05, 2019
Create Date November 13, 2019
Recall Status1 Terminated 3 on October 19, 2021
Recall Number Z-0368-2020
Recall Event ID 83827
Product Classification Degreaser, skin, surgical - Product Code KOY
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.)
Code Information 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
Recalling Firm/
Manufacturer		 Carroll-Baccari, Inc.
6625 White Dr
Riviera Beach FL 33407-1209
For Additional Information Contact Joanna Heyman
561-585-2227
Manufacturer Reason
for Recall		 Product has the potential to be contaminated with Burholderia cepacia.
FDA Determined
Cause 2		 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 in Commerce 24,979 units
Distribution US, Canada, Spain, England, and Australia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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