Personal and monetary injuries sustained due to faulty medical devices tend to be a “hot topic” here at LawInfo.com.  Therefore, I like to stay up to date with medical device recalls.  You can find a list of our “Hot Topics” directly on our homepage at LawInfo.com.

One recall that caught my eye was the Class I recall for custom surgical kits manufactured by H & P Industries, Inc. (H & P) that contains PVP (Povidone Iodine Prep).  PVP is used for preparation of the skin prior to surgery.  H & P Industries, Inc. had previously recalled these kits back in 2011 because they manufactured the PVP products without having a system in place for microbial testing among other things.  Now, Custom Medical Specialties, Inc. is recalling these kits again because the manufacturer hadn’t conducted any microbial testing, the products did not meet proper finished specifications, and the PVP in the surgical kits may cause serious adverse health consequences.  According to the FDA, Class I recalls are the most serious type of recall and may even cause death.

Recalled Product Information:

  • Manufacturing Company: H & P Industries, Inc.
  • Recalling Firm: 
Custom Medical Specialties, Inc.
  • Product Names: Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit.
  • Initial Recall Date: September 30, 2011
  • Reason for Current Recall: There have been no microbial testing, the products do not meet proper finished specifications, and the PVP in the surgical kits may cause serious adverse health consequences, including death.
  • For a list of all the recalled products, go to the FDA recall page.

Additional Information:

Health care professionals and consumers, who have experienced negative reactions using these products, may report their adverse reactions to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  You may report the problem to MedWatch by either mailing in the reporting form, submitting the report online, or by fax to 1-800-FDA-0178.

What to Do if You Have Been Affected by a Recalled Product

If you or a loved one has become injured as a result of a recalled product, you may be entitled to compensation.  It would be beneficial to speak to an attorney specializing in products liability.  Most of the attorneys here at LawInfo.com offer free initial consultations, so it would be advantageous to at least talk to an attorney about your case and get some feedback.

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