Z-0369-2020Class II

Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal...

Name: Z-0369-2020 Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal...
Creator: Carroll-Baccari, Inc.
Published: 2019-09-05
License: https://open.fda.gov/license/

Mavidon Medical Prod / initiated 2019-09-05 / Terminated / root cause: manufacturing process

FDA source

Carroll-Baccari, Inc. began a recall of Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG... on 2019-09-05. FDA classified it as Class II and gives the reason as "Product has the potential to be contaminated with Burholderia cepacia". 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-0369-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-05
Posted: 2019-11-13
Terminated: 2021-10-19
Recalling firm: Mavidon Medical Prod
Product: Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
Product code: KOY Degreaser, Skin, Surgical
Reason for recall: Product has the potential to be contaminated with Burholderia cepacia.
Root cause tag: manufacturing process
FDA root cause: 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: 2445 units
Distribution: US, Canada, Spain, England, and Australia
Product codes and lots: MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0369-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0368-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-13
Z-0369-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-13

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)