Elevated risk U.S. Food and Drug Administration

LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups recall: Burkholderia cepacia

Recall published 6+ years ago

Burkholderia cepacia

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
December 23, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep
Product type
Medical devices

Products covered by this recall

LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers

What the company announced

Mavidon is notifying customers, we are amending our recall and have removed Collodions, Collodion Remover, Medical Adhesive Remover and Acetone from the recall.

Hospital and clinics to STOP using LemonPrep, Pedia Prep, Wave Prep, Cardio Prep manufactured by Mavidon in the Riviera Beach, FL Facility IMMEDIATELY due to potential contamination with Burkholderia cepacia .

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep single use cups due to potential contamination with Burkholderia cepacia . We were notified on December 19, 2019 that samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection that occurred at our facility on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia . Out of an abundance of caution, we are recalling all products manufactured at our facility.

Actions to be taken:

Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.

Fill out the Medical Device Recall form below and email it to [email protected]

We will follow up and give instructions on how to return the product for credit

Burkholderia cepacia is a multi-drug resistant pathogenic microorganism. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals. To date, Mavidon has received one report of adverse event in a neonate related to this product in recall.

Mavidon is notifying of all of its customers by email and phone of this recall. Contact Mavidon at 800-

/MedWatch/ getforms.htm ) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 4 ounce

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Remedy named in the notice: We will follow up and give instructions on how to return the product for credit

Company contact: Mavidon — Consumers: Mavidon, 800-654-0385, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep medical… recalled?

Burkholderia cepacia Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: We will follow up and give instructions on how to return the product for credit

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