New York Firm Recalls Wipes For Bacterial Contamination

Another alcohol prep wipe maker is issuing a large recall over possible bacterial contamination. Professional Disposables International Inc. (PDI), of Orangeburg, New York recalled all lots of five types of nonsterile antiseptic alcohol prep pads over contamination with the Bacillus cereus bacterium, said MSNBC.

As we’ve written, Bacillus cereus is one of the bacteria involved in the massive Triad Group and H&P Industries recalls. That debacle allegedly led to a number of illnesses and deaths. Both Triad Group and H&P Industries Inc. have been accused of manufacturing and distributing alcohol products that were allegedly tainted with dangerous bacteria—Bacillus cereus and Elizabethkingia meningoseptica—both of which are known to lead to rare and deadly infections.

We’ve previously reported that U.S. Marshalls seized $6 million worth of medical products from H&P Industries Inc., which does business as Triad Group, at the behest of the U.S. Food and Drug Administration (FDA). The raid was prompted by the failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations. Triad Group issued several massive recalls of tainted alcohol prep pads, alcohol swabs, alcohol swabsticks, and other products sold under various brand names and because of potential Bacillus cereus contamination. H&P Industries also issued a Povidone Iodine Prep Pad recall because of concerns they could be contaminated with Elizabethkingia meningoseptica, which is associated with flesh eating bacteria disease, meningitis in newborn infants, and pneumonia in ventilator patients.

PDI, Triad, and H&P all share a supplier, according to a PDI spokeswoman who described the detected bacterium as being at “very low levels,” said MSNBC. In the case of Triad and H&P, the problems prompted a plant shut down and no less than eight lawsuits, noted MSNBC.

The PDI recall followed an FDA inspection in which Bacillus cereus was discovered, said Melanie Liebowitz, PDI’s vice president of regulatory compliance, wrote MSNBC. Liebowitz asserted that the tainted products are “well within” mandated specifications and that the recall was implemented after “extensive” talks with the FDA. “We’re a responsible manufacturer and we’re taking prudent action,” she said, MSNBC reported.

Liebowitz said that PDI purchased padding material from Tudor Converted Products Inc. of Summerville, South Carolina, the same firm that supplied pad material to Triad and H&P, MSNBC noted. At least one lawsuit alleges that H&P officials blame bacteria from contaminated Tudor Converted padding; Tudor and Liebowitz disagree, said MSNBC.

H&P industries, Inc. recalled all lots of its Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel. As we’ve explained, H&P manufactured these Povidone Iodine products without a system in place for microbial testing. There was also no system in place for testing of incoming components and there were no procedures in place to prevent objectionable microorganisms from entering and contaminating these drug products. The recall of all of its Povidone Iodine products was due to, and in accordance with, the Consent Decree of Condemnation, Forfeiture, and Permanent Injunction entered in the Eastern District of Wisconsin (Civil No. 2:11-cv-00319-AEG) on June 13, 2011.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.