Product Recalls and Safety Alerts
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Medtronic is recalling certain Monophasic LIFEPAKŪ 500 Automated External Defibrillators (AEDs). This vulontary recall addresses a problem where the AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. See: http://www.medtronic-ers.com/500/.
Medtronic is recalling the Lifepack 12 Defibrillators with Adaptiv bi-phasic technology. The voluntary recall is due to erroneous resetting of user specified Joule settings. This unit is commonly used by ALS agencies.
Access Cardio is recalling ALL of it's Automated External Defibrillators (AEDs) due to 1. Potential Failure of the Shock Delivery Circuit and 2. Potential of the AED to Turn on Unexpectedly. For more information, please visit: http://www.fda.gov/oc/po/firmrecalls/accessCardio11_04.html
Frieghtliner recalls trucks equipped with air brakes and Bendix Anti-Lock Braking System (ABS) EC 17-1030R manufactued between 3/98 and 8/2000. The full press release is available at the Frieghtliner LLC web site.
- Gam Industries advises that their blue Burn Sheets DO NOT include an expiration date but will begin to change color after 3 years and start to self destruct or
disintegrate after 4 years. A white paper sheet inside each transparent package includes a LOT #.
The first 3 digits of this LOT # is the Julian Date and the last digit is the last digit of the year of
manufacture. So, LOT# 3657 is the 365th day of 1997 or 12/31/97 and 0017 would be the first day of 1997
An EMS supplier in Connecticut reported a case where 2 such burn sheets (manufactured in 1992) were opened on the scene and appaeared to be "confetti".
EMS agencies are advised to establish a protocol for when to discard burn sheets.
- Clinipad Corporation is voluntarily recalling all Povidone
Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol
Antiseptic products (swabsticks, prep pads, towelettes, and pouches), as
well as, Cliniguard Protective Dressing labeled as "sterile"
that were manufactured over the last three years. The company has
confirmed microbial contamination in some lots of its sterile products,
including one lot with Pseudomonas aeruginosa, Stenotrophomonas
maltophilia, and Coagulase Negative Staphylococcus.
For more information, visit the FDA site: http://www.fda.gov/medwatch/safety/2000/safety00.htm#clinip
- Physio-Control has issued a warning regarding the care and use of lithium batteries used in LIFEPAK 500 AEDs. Althouhg the batteries are believed to be safe, we suggest that you reda this letter from PHYSIO-CONTROL if using this model AED.
- The INFORMED EMS Field Guide 12th Edition (product number SAF
100EFG) has been recalled by the manufacturer. An adhesive label is
available to correct the affected section in the book. These books have a
typographical error in the emergency medication section for the dosage of
dopamine. You will find this error on page 40 of your field guide. Place
the adhesive label over the incorrect information which you will find
under dopamine- 50 kg patient. The error affects only a 50kg patient
receiving a 15 ug/kg minute dose. The error would cause a patient to
receive the full dose of dopamine, rather than 3/4 of the full dose, as
intended. All other doses for dopamine are correct in the guides.
If you have any questions feel free to call the Fox International customer
service line at 800-369-4685.
- Kiddie Safety recalls CO Alarms All
"Nighthawk" as well as "Lifesaver"
models 9CO-1 & 9CO-1C carbon monoxide alarms have
been voluntarily recalled by the manufacturer. About 1
million units are affected. A defect could cause the
alarm to sound late or not at all. For more information,
visit the Kiddie web site
- The FDA and NIOSH have issued a warning regarding the use of aluminum oxygen regulators. See the full report at the FDA site.
- Allied Healthcare Products has announced a recall of
all oxygen regulators sold under the Life Support
Products (LSP) brand to replace aluminum components
in the units' 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. Models subject to this recall are:
LSP 106, LSP 270, LSP 280, LSP 370 and LSP 735 series
regulators. These LSP oxygen regulators, can be serviced
at pre-existing authorized service centers nationwide.
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 aluminum
high-pressure parts with brass parts.
To reduce risk during use of any oxygen regulator by keep
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.
Customers should receive a mailing with details about how
to have their regulators serviced. For more info, contact
Allied's Recall Coordinator at 800-216-4624 (Monday through
Friday, 8:00 a.m. to 5:00 p.m. CST) or by e-mail at: RRC@alliedhpi.com.
- Laerdal has issued a recall for battery charger units for it's Heartstart® semi-automatic defibrillators. The recall affects the charger only (part # 902850) and will not affect operation of the AED itself. For more info. contact Laerdal at 1-800-648-1851.
To report news or important safety issues, please write to: firstname.lastname@example.org
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