MIKE G
02-08-11, 13:07
As some of you may know, I own Austere Provisions Company and we sell trauma medical kits among other items. Over the weekend we received notification of a recall of a component that is included in a number of the kits that we sell as well as with the nasal airways that we sell.
If you have received (either by purchase or give away) one of the following items:
Austere Provisions Company IC3 Kit (http://www.austereprovisions.com/ProductDetails.asp?ProductCode=IC3K-1)
Austere Provisions Company Comprehensive Trauma Kit Built Under Contract For LMS Defense (http://www.austereprovisions.com/ProductDetails.asp?ProductCode=APC+CBOK-LMS)
Please contact me at Mike@austereprovisions.com for a replacement packet of lubricating jelly.
I have included the text from one of the notifications regarding this product recall.
*******************
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
*******************
As well, for all other health care professionals be sure to check your equipment. The EMS agency I work for has had to replace all the Lubricating Jelly packets from a number of prepackaged kits to include King Airways.
Thanks,
If you have received (either by purchase or give away) one of the following items:
Austere Provisions Company IC3 Kit (http://www.austereprovisions.com/ProductDetails.asp?ProductCode=IC3K-1)
Austere Provisions Company Comprehensive Trauma Kit Built Under Contract For LMS Defense (http://www.austereprovisions.com/ProductDetails.asp?ProductCode=APC+CBOK-LMS)
Please contact me at Mike@austereprovisions.com for a replacement packet of lubricating jelly.
I have included the text from one of the notifications regarding this product recall.
*******************
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
*******************
As well, for all other health care professionals be sure to check your equipment. The EMS agency I work for has had to replace all the Lubricating Jelly packets from a number of prepackaged kits to include King Airways.
Thanks,