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Posted 10/18/11

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.

» Recall Form

 

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Posted 5/12/11

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

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Class I Recall, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm254929.htm

 

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_11_2011_0850&cpp[type]=S

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

 

 

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Posted 3/15/11

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.

» Announcement

» Recall Form

 

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Posted 3/8/11

King Systems LTS-D Airways Recalled

Click here to read the complete recall notice online

On January 24, 2011 King Systems issued a voluntary recall involving the LTS-D Airway:

King Systems Product Code	Product Description	Lot Number(s)
KLTSD414	KING LTS-D Kit, Size 4-5/Case	IV715
KLTSD405	KING LTS-D, Size 5	201011-169

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.

 

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Posted 1/7/11

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  

Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

 

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Posted 1/4/11

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.

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238624.htm

 

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Posted 7/9/09

URGENT - Medical Device Recall

HeartStart XL M4735A Defibrillator/Monitor
Device Does Not Turn On Due to Switch Failure

For more information go to http://www.ogs.state.ny.us/purchase/spg/pdfdocs/CL718.pdf

 

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Posted 4/10/09

ZOLL AED Plus Defibrillator

Audience: Emergency medical personnel
ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter at link below for details.

Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer letter at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#ZOLLAEDplus

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Posted 3/4/09

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.

Link to Article: http://www.24x7mag.com/joltnews/2009-02-17_06.asp?frmTagFilePath=%2Fregulations_standards.asp

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Posted 9/12/08

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:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#LifePakCR