Z-1551-2020Class II

Wave Prep Tubes (1710-03) and single use cups (17--00-24)

Name: Z-1551-2020 Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Creator: Carroll-Baccari, Inc.
Published: 2019-12-23
License: https://open.fda.gov/license/

Mavidon Medical Prod / initiated 2019-12-23 / Terminated / root cause: manufacturing process

FDA source

Carroll-Baccari, Inc. began a recall of Wave Prep Tubes (1710-03) and single use cups (17--00-24) on 2019-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1551-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-03-20
Terminated: 2021-09-28
Recalling firm: Mavidon Medical Prod
Product: Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Product code: KOY Degreaser, Skin, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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 [email protected]
Quantity in commerce: 1444 units
Distribution: Nationwide, Canada, UK, Spain, Australia
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1551-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1548-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1549-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1550-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1551-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code KOY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)