Recall - Furosemide Injection USP 100 mg (10 mg/ml) 10 ml Ansyr Syringes
A recall has been issued for Furosemide Injection, USP, 100 mg (10 mg/mL), 10 mL Ansyr pre-filled Syringes manufactured by Hospira. The effected lot number is 85-246-EV. This recall does not affect Furosemide packaged in vials.
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock
AUDIENCE: Emergency Medicine, Risk Manager
ISSUE: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
BACKGROUND: AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
RECOMMENDATION: Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction
Read the MedWatch safety alert, including a link to the FDA Class I Recall, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Voluntary Amiodarone Recall:
There has been a voluntary nationwide recall of all lots of Amiodarone Injection 150mg/3ml pre-filled syringes. The recall is not due to any problems with the medication itself. The recall is due to the incompatibility of the syringes with certain IV tubing – an issue we have previously identified and are aware of. If you carry pre-filled Amiodarone Syringes please review information and your stock and proceed as directed.
Posted 3/8/11King Systems LTS-D Airways Recalled
On January 24, 2011 King Systems issued a voluntary recall involving the LTS-D Airway:
This recall has been initiated due to product below specified hardness. The tubes are too pliable and may be difficult to use for intubation. There is a possibility that the tube could fold over in the narrower areas of assembly.
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
Sold by Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, Conzellin
AUDIENCE: Pharmacy, Consumer
ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
RECOMMENDATION: If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the Press Release, at:
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
AUDIENCE: Family Practice, Pharmacy, Consumer
ISSUE: The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. Administration of this defective product could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death.
There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used resulting in an administered amount that is 5 times the recommended dose. In the hospital setting, the vials are often not accompanied by the rest of the packaging, making it more likely that such a dosing error could occur. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.
BACKGROUND: This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this recall. This product was distributed nationwide and Puerto Rico.
RECOMMENDATION: Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc.). Wholesalers and retailers should return the product to the address stated in the firm Press Release.
Read the MedWatch safety alert, including a link to the company press release, at:
URGENT - Medical Device Recall
HeartStart XL M4735A Defibrillator/Monitor
For more information go to http://www.ogs.state.ny.us/purchase/spg/pdfdocs/CL718.pdf
ZOLL AED Plus Defibrillator
Audience: Emergency medical personnel
Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer letter at:
FDA Enforces Stryker Medical Chair Recall
Under Recalls and Field Corrections: Devices—Class II, the weekly FDA Enforcement Report of February 11 reports the ongoing recall initiated by Stryker on November 18, 2008, of its medical stair-PRO stair-chair.
The Stryker Medical Division of Stryker Corp, Portage, Mich, recalled 213 chairs distributed nationally and in India, the Netherlands, and the United Kingdom because the handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
The recall involves the Stryker medical stair-PRO stair-chair with wheels, patient transport device, model 6251, recall # Z-0648-2009; the Stryker medical stair-PRO stair-chair with wheels and a track system, patient transport device, model 6252, recall # Z-0649-2009; and the Stryker medical stair-PRO evacuation chair civilian use stair chair, patient transport device, model 6253, recall # Z-0650-2009.
Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Recall Notice regarding this issue:
Spread the word, The long awaited Medtronic and Zoll AED upgrades have arrived. If your agency has a LP-500 AED with the OK box in the handle you can contact any of the following entities and have your equipment upgraded at no expense. If you have a Zoll AED+ or other AED's and are not sure if they can upgraded contact our office and we will attempt to assist you. Jefferson County EMS - 786-3760 Lewis Cty. Search and Rescue - 376-7745 St. Lawrence Cty. - NCEMS @ 379-3977
These free upgrades are provided by the North Country REMSCO.
PROGRAM AGENCY Newsletters
North Country Emergency Medical Services Program Agency
of Jefferson, Lewis & St. Lawrence Counties
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