Public Safety 
Product Recalls and Safety Alerts

[ Home | Events | NJ EMS Online | News ]

To report news or important safety issues, please send me Email with the information.

• Medtronic is recalling certain Monophasic LIFEPAK® 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 or 1/1/97.

  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:

1. the oxygen tank, cylinder valve and regulator should be free of all contaminants;
2. the cylinder valve should be opened slowly whenever the unit is used to minimize heat of rapid compression in the regulator;
3. 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: john@hilltopassociates.com

[ Home | Events | NJ EMS Online | News ]

© 2005 John Staunton