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Another recall of products manufactured by Triad and sold under a bunch of other names.
This recall is not for contamination, but for documentation.
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Click on image to make larger.
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FDA Comments:
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.[1]
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According to the “Urgent Medical Device Recall” letter, the problem is –
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.[2]
This is not the identification of any actual contamination, but a problem with the documentation of the sterilization process.
No contamination.
No identified problem with the sterilization process.
Only an inability to document that the sterilization was performed according to protocols.
This is something to consider when documenting patient care. Triad is having to recall all of their product distributed from January, 2007 through December 2010 because of documentation. 4 years worth of work wasted because of faulty documentation. How important is documentation?
We do need to pull all of this product from our supplies, but there still does not appear to be any case of actual contamination or any case of faulty sterilization.
This is something we should consider when we do not take our documentation seriously.
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Updated several times with significant changes since 12:00. Final edit at 12:35 02/15/11.
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Footnotes:
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[1] Triad Sterile Lubricating Jelly
FDA
Recall Notice
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[2] Urgent Medical Device Recall
Triad
Voluntary Recall Letter in PDF format
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