Crickit®, Surgical Kits—which may contain tainted Triad Povidien Prep Pads—are being recalled under the direction of the U.S. Food and Drug Administration (FDA) and involves North American Rescue, LLC Surgical Crichothyroidotomy Kit or Crickit®, due to potential contamination of the Povidien Iodine Prep Pads, manufactured by Triad Group. This recall is a follow up to the May 5, 2011 recall.
North American Rescue, LLC stated that it has successfully contacted 97% of its customers and requested its customers contact its customer service department for return instructions. North American Rescue, LLC also requests that all recipients who have further distributed these recalled devices to advise their customers to facilitate the removal of all affected product. North American Rescue also noted that this is its final attempt to reach out to customers who may still be in possession of these recalled and defective devices.
The Crickit® Kit component is found inside a larger kit—the NAR Medic Trauma Pack Kits—which are available in for colors for the following codes. This recall involves Part Number: 10-0017: Crickit®, or Surgical Cricothyroidotomy Kit; a complete list of lot numbers can be accessed on the FDA’s web site at: http://www.fda.gov/Safety/Recalls/ucm290639.htm. Only the Crickit® component is involved
• Surgical Cricothyroidotomy Kit or Crickit® product code 10-0017.
• Medic Trauma Pack Kit – BLK (Black), product code 80-0070.
• Medic Trauma Pack Kit – ODG (Green), product code 80-0071.
• Medic Trauma Pack Kit – COY (Tan), product code 80-0072
• Medic Trauma Pack Kit – DUC (Camouflage), product code 80-0096
Affected lot numbers appear on the NAR website at www.narescue.com. This product is discontinued and no longer included in the Medic Trauma Pack Kits.
According to the recall conducted by Triad Group, the prep pads may be contaminated with the bacterium Elizabethkingia meningoseptica, which could potentially result in life threatening infections, especially in at-risk populations, such as the immuno-suppressed and surgical patients. North American Rescue was notified in April 2011 by H&P Industries that the Triad +, item number 11-9932, from Lot numbers beginning with the digits 8,9, 0 or 1 was subject to a recall. North American Rescue ceased shipments of the Crickit®, ® Surgical Crichothyroidotomy Kits on April 23, 2011. This product was distributed from April 30, 2009 to April 22, 2011, in the United States, Switzerland, Denmark, Slovakia, Slovenia, Spain, Austria, Norway, England, Estonia, Japan, South Africa, and Canada.
Customers are instructed to immediately discontinue use of the Crickit® convenience kits and contact NAR Customer Service for instructions product return. Only the Crickit® should be returned from the Medic Trauma Pack Kits. North American Rescue can be reached, toll-free, at 1.888.689.6277, Monday through Friday, 8:00 a.m. to 5:00 p.m., Eastern Time (ET). Additional information on the Triad recall may be found at http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2011/ucm247658.htm.
As we’ve written, the massive Triad Group and H&P Industries recalls 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 also 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 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 Povidien 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.