Update on Povidone Iodine Prep Pads (H & P Industries) Recall for Possible Contamination by Microbial Organisms

Consumers, risk assessment managers, pharmacists, surgeons and the medical fraternity at large are being updated on the status of H&P Industries product recall for Povidone Prep Pads.

The Povidone Prep Pads,a product of H & P Industries, recently underwent a major voluntary recall that affected all the product lots, with most of the affected batches having private labels.

FDA Alert on H & P Industries Povidone Prep Pads

Following various laboratory tests conducted by the FDA, it was established that traces of Elizabethkingia meningoseptica also known as Flavobacterium meningosepticum or Chryseobacterium meningosepticum.

The use of Povidone Prep Pads that have been contaminated by the bacteria Elizabethkingia meningoseptica (or any other bacteria) could cause adverse health risks, particularly amongst risk groups that include:

• immunosuppressed patients
• newborn babies (neonates)
• surgery patients

FDA also includes the fact that there are only limited treatment options for infections by Elizabethkingia meningoseptica bacteria.

Background of Povidone Prep Pads

Povidone Iodine Prep Pads are a product of H&P Industries, and are used as padding for scrapes, bruises, grazes, burns, and minor cuts so as to prevent infection through such skin injuries.

They are also used pre-surgery as antiseptic pads used in preparing the patient’s skin for surgery.

Povidone Prep Pads were previously distributed in a distribution network that covered the entire nation, and were packaged either in batches of 100 Povidone packs or in single packs.

List of recalled products from H&P Industries

Not all of the recalled Povidone Iodine Prep Pads from H&P Industries go by the same tradename. However, regardless of the tradename, all Povidone Prep Pads were recalled due to bacterial contamination and the complete list is as follows:

• North Safety
• NAR Surgical Crichothyroidotomy Kit (Crickit kits)
• Cardinal Health
• Lee Medical International (Custom Dialysis kits)
• Total Resources
• Medical Specialties
• Atwater Carey
• VHA
• Triad Plus
• Triad (First Aid kits)

FDA Recommendation

The FDA’s official recommendation is stated as follows:

“ Healthcare organizations should contact H&P Industries Customer Service to arrange a return.

If a consumer has any of these types of products in their possession, they should not use the product.”

Contacting the FDA to report cases relating to Povidone Iodine Prep Pads

Any adverse side effects or incidences relating to the use of Povidone Iodine Prep Pads from H&P Industries should immediately be reported to the FDA.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

.

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.