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U.S. Department of Health and Human Services

Class 2 Device Recall Wave Prep

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 Class 2 Device Recall Wave Prepsee related information
Date Initiated by FirmDecember 23, 2019
Create DateMarch 20, 2020
Recall Status1 Terminated 3 on September 28, 2021
Recall NumberZ-1551-2020
Recall Event ID 84587
Product Classification Degreaser, skin, surgical - Product Code KOY
ProductWave Prep Tubes (1710-03) and single use cups (17--00-24)
Code Information All Lots
FEI Number 3017189082
Recalling Firm/
Manufacturer		 Carroll-Baccari, Inc.
6625 White Dr
Riviera Beach FL 33407-1209
For Additional Information ContactJoanna Heyman
561-585-2227
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce1444 units
DistributionNationwide, Canada, UK, Spain, Australia
Total Product Life CycleTPLC 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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