Recall Notices

Blue Burn Sheets Manufactured by Gam Industries Recently rescuers responded to a call having a burn victim. The rescuers opened and applied two of the blue Gam Industries burn sheets to the patient. These sheets when opened up over the patient were in a state similar to confetti. They had disintegrated in their packages.

Gam Industries advised us that the Burn Sheets DO NOT have an expiration date printed anywhere on them. The manufacturer stated that they start to change color after 3 years and start to self destruct or disintegrate after 4 years. There is a LOT# on the white paper sheet inside the see through packages. The LOT# `s first 3 numbers is the Julian Date and the last digit is the last digit of the year of production. ie LOT# 3657 is the 365th day of 1997 or 12/31/97 and 0017 would be the first day of 1997 or 1/1/97. (the ones used by the service were manufactured in 1992).

You need to be aware of this situation and establish your own protocol for when to discard burn sheets. From this date forward all burn sheets sold from Common Cents EMS Supply will have a 4" x 6" sticker on them explaining the LOT#'s and advising the owner to discard them at an appropriate length of time.

Embryo's Hot Sack Embryo recently received notice that an intravenous warmer manufactured and sold by C.F. Electronics has allegedly overheated, resulting in the suspension of this product's sales and use in the United Kingdom. C.F. Electronics manufactures similar warmer products, the "Hot Sack I and II's" for Embryo. As a result of C.F. Electronic's product suspension, sales and use of Embryo's "Hot Sack I and II" products have been suspended in the United Kingdom. Embryo has voluntarily suspended worldwide sales of its "Hot Sack I and II" products and is currently working with the manufacture to resolve this issue before resuming sales. There are no known incidents of patient injury resulting from the alleged overheating of the "Hot Sack I and II" products.

While the manufacture is investigating alleged product overheating, we are advising our customers to temporarily discontinue use of their "Hot Sack I and II" products. Should you decide to continue use of these products despite this warning please be advised to take additional precautions to ensure that the fluid has not overheated before infusion. Embryo will advise you if further action is required following the manufacturer's investigation.

Allied Healthcare Products Inc oxygen regulators February 4, 1999 St Louis MO.

Allied Healthcare Products Inc is recalling all oxygen regulators sold under the Life Support Products brand to replace aluminum components in the unit's high pressure chambers with brass components. The action is being taken in response to reports of fires and explosions, the exact causes of which remain unknown.

The models subject to this recall consist of the LSP 106, LSP 270, LSP 280, LSP 370, and LSP 735 series regulators. Users of the LSP oxygen regulators which include fire departments and emergency medical services units, will be able to have the parts replaced at pre-existing authorized service centers nationwide.

This recall is being undertaken in cooperation with the United States Food and Drug Administration to minimize the potential for fires and explosions, which are an inherent risk with any high pressure oxygen delivery system. Fires and explosions can occur in the tanks, cylinder valves and regulators of such systems when virtually any type of contaminants-including hydrocarbons, metal shavings or even dust particles-are present or introduced during handling and maintenance, or when the tanks are refilled with gas.

In may 1997 Allied conducted a recall to add a sintered bronze filter to the LSP 270 series regulator only. All of the 270 series regulators should have already be fitted with a sintered bronze filter. ALTHOUGH THE LSP 270 SERIES REGULATOR MAY HAVE ALREADY BEEN RETROFITTED WITH THE SINTERED BRONZE FILTER, IT IS ESSENTIAL THAT THE INTERNAL HIGH PRESSURE PARTS BE REPLACED WITH BRASS COMPONENTS TO ENHANCE SAFETY.

ALL LSP REGULATORS WITHOUT A SINTERED BRONZE FILTER AND ALL REGULATORS MANUFACTURED BY LSP'S PREDECESSOR COMPANY, ROBERT SHAW CONTROLS COMPANY, INC, SHOULD BE TAKEN OUT OF SERVICE IMMEDIATELY. If the user is unable to determine if a sintered bronze filter has been installed, Allied should be contacted for assistance in this determination.

Due to industry-wide fires and Allied's understanding that the FDA is recommending the elimination of all aluminum in oxygen regulators, Allied has voluntarily initiated the recall to replace all high pressure parts with brass parts. THIS IS STRICTLY AN INTERIM MEASURE that will enable the regulators to be used during the period required to manufacture the new brass regulators. Allied will issue another notification when the new brass regulators become available.

"This recall reflects Allied's strong commitment to manufacturing the highest quality products and to the safety of all of our customers," said Uma Nandan Aggarwal, Allied's chief executive officer.

Allied is aggressively undertaking development and enhancement of it's new brass regulator series and will be making available a trade in program once the new brass regulators are available.

Users can reduce risk during use of any oxygen regulator by keeping in mind the following precautions:

*) the oxygen tank, cylinder valve and regulator should be free of all contaminants. *) the cylinder valve should be opened slowly whenever the unit is used to minimize heat of rapid compression in the regulator *) users who refill their own oxygen cylinders should take extra care to avoid the introduction of contaminants during the filling process.

Allied will have the service centers authorized to handle the recall established within the next few weeks. Customers should receive a mailing with details about how to have their regulators serviced or they may contact Allied's recall coordinator at 800-231-5273 (monday through Friday between the hours of 8am and 5pm CST) or by E-Mail at RRC@alliedhpi.com for more information.

Sorry this was so long but Common Cents EMS Supply wants to make sure that you are all well informed of the situation.

Please feel free to E-mail us if you have any questions or if you have any of these regulators E-Mail us and when they provide us with any updated information we'll E-Mail you directly.

Any customers who have purchased any of these regulators from us will be notified directly from us. The regulators which we actively promote which are on our website and in our current catalog all have bronze internal parts and should have no problems.