Date Initiated by Firm |
December 23, 2019 |
Create Date |
March 20, 2020 |
Recall Status1 |
Terminated 3 on September 28, 2021 |
Recall Number |
Z-1551-2020 |
Recall Event ID |
84587 |
Product Classification |
Degreaser, skin, surgical - Product Code KOY
|
Product |
Wave Prep Tubes (1710-03) and single use cups (17--00-24) |
Code Information |
All Lots |
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 |
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 |
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 in Commerce |
1444 units |
Distribution |
Nationwide, Canada, UK, Spain, 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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