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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit® Convenience Kits Because of Possible Health Risk Related to Nationwide Recall of Triad Povidone Iodine Prep Pads

 

Contact:
Consumer
1-888-689-6277, Monday through Friday, 8:00am to 5:00pm (ET)

FOR IMMEDIATE RELEASE – February 6, 2012 – Greer, SC, February 6, 2012-Under the direction of the FDA, North American Rescue, LLC (NAR) today announces the market recall of the NAR Surgical Crichothyroidotomy Kit or Crickit®, due to potential contamination of the povidone iodine prep pads, manufactured by Triad Group. This recall is a follow up to the recall initiated on May 5, 2011. North American Rescue, LLC has successfully contacted 97% of our customers and requested they contact our customer service department for return instructions. North American Rescue, LLC requests all recipients who have further distributed these devices to forward this communication to their customers to facilitate the removal of all affected product.

This is North American Rescue’s final attempt to reach out to customers who may still be in possession of these devices.

The Crickit® Kit component may be found inside a larger kit, the NAR Medic Trauma Pack Kits, available in 4 colors for which the codes are listed below. Only the Crickit® component is being recalled. Please see the attached lot numbers for the affected Crickit® Kits. The affected lot numbers for the Medic Trauma Pack Kits can be found on the North American Rescue website www.narescue.com. Please note that this product has been discontinued and therefore is no longer included in the Medic Trauma Pack Kits.

Product Code Item Description Lot Numbers
10-0017 Surgical Cricothyroidotomy Kit or Crickit® See attachment
80-0070 Medic Trauma Pack Kit – BLK (Black)  
80-0071 Medic Trauma Pack Kit – ODG (Green)  
80-0072 Medic Trauma Pack Kit – COY (Tan)  
80-0096 Medic Trauma Pack Kit – DUC (Camouflage)  

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, including immune 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 04/23/11. This product was distributed from 4/30/09 to 4/22/11 in the US, Switzerland, Denmark, Slovakia, Slovenia, Spain, Austria, Norway, England, Estonia, Japan, South Africa and Canada . Further, North American Rescue, LLC is conducting this voluntary recall with full knowledge of the Food and Drug Administration (FDA).

Customers are instructed to immediately discontinue the use of the Crickit® convenience kits and to contact North American Rescue Customer Service for instructions for returning the product. Only the Crickit® should be returned from the Medic Trauma Pack Kits.

Consumers with questions may contact North American Rescue at 1-888-689-6277, Monday through Friday, 8:00am to 5:00pm (ET).
Additional information on the Triad recall may be found at http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2011/ucm247658.htm.

Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax
• Online: http://www.fda.gov/medwatch/report/htm
• Mail: Use FDA form 3500 available at http://www.fda.gov/MedWatch/getforms/htm. The address for submission is included on the form.
• Fax: 1-800-FDA-0178

 

Part Number: 10-0017    Description: Crickit or Surgical Cricothyroidotomy Kit

Lot #
21096
21420
21421
21422
21423
21424
21910
21911
21912
21913
22151
22152
22289
22290
22344
22345
22346
22347
22725
22726
22727
22728
22946
22947
22948
22949

 

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