Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

FDA Warning: Customed Surgical Packs May Not Be Sterile

FDA Warning: Customed Surgical Packs May Not Be Sterile

January 12, 2016 — The FDA is warning hospitals not to use Customed convenience packs and trays for surgical procedures because they may not be sterile and could cause infection or death.

The sterility of medical devices used in surgery is extremely important to prevent infections. Customed has now issued three Class I recalls numerous additional Class II recalls for products made since 2009 in Puerto Rico.

The problem is that the plastic packaging can get stuck together during the sterilization process. When separated, the packaging could tear and allow microorganisms inside. The FDA warns:

“There is significant risk of compromised sterility and use of a contaminated product, whether the package is damaged or not. The products have been exposed to uncontrolled and inadequate storage conditions and there are serious deficiencies in the manufacturing process.”

Customed initiated a recall in June 2014 due to potential contamination. In October, Customed expanded the recall and stopped distribution. The FDA inspected Customed and issued a warning letter in December 2014 about problems with sterility and package design.

Surgical convenience packs and trays may contain items like exam gloves, absorbent towels, gauze sponges, surgical table covers, gowns, and suture kits. They are widely used in general surgery, including dental, obstetrical, and gynecological procedures.

Do I have a Medical Device Lawsuit?

The Schmidt Firm, PLLC is currently accepting infection induced injury cases in all 50 states. If you or somebody you know has been injured by a contaminated medical device, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.