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Class 2 Device Recall Lemon Prep |
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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
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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
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For Additional Information Contact |
Joanna Heyman 561-585-2227
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Manufacturer Reason for Recall |
Product has the potential to be contaminated with Burholderia cepacia.
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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
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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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