Sunday, February 13, 2011

PRODUCT RECALL

Austere Provisions was recently notified of the recall of the "Triad Sterile Lubricating Jelly" that we include in our trauma kits and attached to the nasal airways that we sell. Due to the fact that we provide these as give-aways for courses, charity events, and product demos we are trying to get the word out as far as possible. We will replace the lubricant packet at no cost to the customer/recipient of the kit but we need to know if you still have the kit in hand. So, if you have either an IC3, LMS Comprehensive kit, or individual nasal airway that you purchased from Austere Provisions Company please email me at mike@austereprovisions.com for info on how to receive the replacement.

As of 02/13/2011 any kits or airways leaving the shop were stocked with a replacement equivalent component not effected by the recall.

Detailed information about the recall from the manufacturer:

URGENT MEDICAL DEVICE RECALL
This is to inform you of a product recall involving Sterile Lubricating Jelly manufactured by Triad Group.
This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the
validation of the gamma radiation sterilization cycles for these products. We are initiating this recall because use
of inadequately sterilized product might result in patient infection.
This recall extends to all Lots of Sterile Lubricating Jelly remaining within their labeled expiration dating (three
years), including all Lot numbers beginning with the digits 7, 8, 9, or 0. We began shipping the Lots of product
subject to this recall in January, 2007
Please immediately examine your inventory and quarantine product subject to recall – any stock of Sterile
Lubricating Jelly manufactured by Triad Group. In addition, if you may have further distributed this product, please
identify your customers and notify them at once of this product recall. Your notification to your customers may be
enhanced by including a copy of this recall notification letter.
This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent
potential patient harm.
Please complete and return the enclosed response form as soon as possible and return the recalled product to
Triad Group.
If you have any questions please call Triad Group Customer Service Monday through Friday, between the hours
of 8:30 A.M. and 4:00 P.M. Central Time: 262-538-2900 ext 2761.
This recall is being made with the knowledge of the Food and Drug Administration.
Yours truly,
Jack Waterman
Jack Waterman
Regulatory Affairs Manager

__________________________________

Thanks for your patience as we work to correct this issue,

Mike Griffin
Owner
Austere Provisions Company

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