Triad Not-So 'Sterile' Lubricating JellyDear Ones:
Once in a while we come across a 'recall situation' that is so NOT forth-coming and disclosive that it fairly begs for continued, intense scrutiny.
Such is the case with Triad Products.
My main focus of concern at this time is Triad's 'Sterile Jelly' Recall, which received very little press to date, but which demands greater scrutiny now, in my opinion.
Just for the record, here is their company 'recall page':
And here is the link for all FDA notices related to 'Triad Group Recalls':
(If you use the above, be sure to 'refresh' the search tool embedded in it.)
The Triad lube jelly link is dated way back to this past December 23, 2010
LINK: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm243399.htm Triad's so-called 'sterile lube jelly' is used to lubricate everything from catheters to fingers, endoscopes and other medical instruments.
BRANDS AFFECTED BY TRIAD'S STERILE LUBE JELLY RECALL:
According to Triad, itself, the following 'brand names' are involved in this lube jelly recall:
ScheinA cursory examination of Triad's 'products recall page' reveals that the company is not very 'forthcoming' with information, except to identify the products involved:
Triad Group, Triad Sterile Lubricating Jelly
Recall Class: Class II
Date Recall Initiated: December 23, 2010
Products: Sterile Lubricating Jelly, packaged in:
5 gram tubes
2 ounce and 4 ounce tubes
4 ounce bottles
3 and 5 gram packets
This recall affects all Triad lubricating jelly packages with lot numbers beginning with the numbers 7, 8, 9, or 0. If these packages are part of kits, packs, or trays, the lot numbers will only appear on the lubricating jelly packages.
The Triad lubricating jelly products were distributed by Triad from January, 2007 through December 2010. These products may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.
FDA will update this webpage when additional information is available.
The following table provides brand names, distributors, and product identifiers (catalog or reorder numbers) known at present:
BRAND NAMES FIRM NAMES CATALOG/
REORDER #s PRODUCTS
Allegiance Cardinal Health LJT2
LJT5 Net Wt. 2 oz.
Net Wt. 3g
Net Wt. 4 oz.
Net Wt. 5g
Select Medical Products PSS World Medical, Inc. 137
Novaplus Novation, Inc. V10-8344
V10-8917 Net Wt. 3g
Net Wt. 4 oz.
Net Wt. 2 oz.
Triad Plus Triad Group, Inc. 10-8917
10-8500 Net Wt. 2 oz.
Net Wt. 5g
Net Wt. 3g
Net Wt. 5g
Net Wt. 4 oz.
Net Wt. 4 oz.
IMCO Independent Medical Co-op, Inc. 8919-IMC Net Wt. 4 oz.
Performance McKesson Corporation,
McKesson Surgical 66-8919 Net Wt. 4 oz.
Henry Schein Henry Schein, Inc. 104-9637 Net Wt. 4 fl. oz.
Under Useful Links below, see also firm recall letter and recall webpage, related FDA News Release on non-sterile alcohol prep pads, and related firm Press Releaseon Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks.
Use: This product helps to provide easy insertion of a medical device (such as a catheter or an endoscope) or gloved fingers into body openings.
H & P Industries, Inc., doing business as, Triad Group
700 West North Shore Drive
Hartland, Wisconsin 53029-8358
Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
Public Contact: Customers with questions may contact Triad Group Customer Service at 1-262-538-2900 ext. 2761, Monday through Friday, from 8:30 AM through 4:00 PM, Central Time or your distributor.
FDA District: Minneapolis
On December 22, 2010, the company sent an “Urgent Medical Device Recall” letter to all its customers by certified mail. The letter described the issue, identified the affected products with the lot numbers beginning with the digits 7, 8, 9, or 0, as well as the action to be taken by the customers.
Triad Customers (Distributors, and kits, packs, or trays’ manufacturers) were instructed to:
IMMEDIATELY EXAMINE their inventory.
QUARANTINE only lubricating jelly products.
IMMEDIATELY NOTIFY their customers if the recalled product was further distributed.
COMPLETE AND RETURN the enclosed Recall Acknowledgement form by FAX at 1-262-538-2947 or mail to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Harland, Wisconsin 53029, OR
RETURN the recalled product to the appropriate company, if not the Triad Group.
Triad sterile lubricating jelly products have been incorporated into a variety of procedural and convenience kits, packs, or trays with other medical devices and/or drug products.
Healthcare facilities: IMMEDIATELY CONTACT your kit, pack or tray suppliers to determine whether the products stocked at your facility are impacted by the Triad recall. Your supplier should provide you with documentation on whether your products are affected by the recall.
FDA is instructing manufacturers and repackers who have incorporated the recalled products into their kits, packs or tray to PROMPTLY CONDUCT A SUB-RECALL and submit their recall strategies to their FDA District Office.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.
Triad Recall Letter 23
Triad Recall Webpage4 5
FDA News Release - Safe Use of Non-Sterile Alcohol Prep Pads 6
Firm Press Release on Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks 7
Foley Catheters which require the use of a 'sterile lubricating gel'We get a somewhat better 'handle' on what may be going on with Triad's lube jelly by reading it's "URGENT MEDICAL RECALL LETTER" dated last Dec. 22, 2010:
"This is to inform you of a product recall involving Sterile Lubricating Jelly distributed 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.
That which is highlighted above is quite an understatement, since Triad products have been implicated in a number of very serious Bacillus cereus infections (see alcohol pads, swabs and swabstick articles.)
But, to date, we can find scant information on exactly what kind of 'contamination' affects the recalled Triad lube jelly.
My advice to you, dear Readers, is to REFRAIN FROM USING TRIAD PRODUCTS, since clearly The Triad Group has a number of 'sterilization issues' with a number of it's products.
Until more information is released by both Triad, itself, the FDA, private laboratories and third-party witnesses and 'discoverers', it is wise to be cautious.
Do not depend upon either a commercial manufacturer NOR a government agency to look out for your health!
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And, as always, consult with your personal health care advisor to get the very best input on protecting your health and that of your loved ones.
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"