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Home > Recalled Products > Medical Devices > Defect > STAT-Check, Medline Resuscitator Bags

Recall: STAT-Check, Medline Resuscitator Bags

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On 2018-06-01, the FDA announced that SunMed Holdings is conducting a recall on Resuscitator Bags due to a possible defect. The recalled products were sold under the brand name(s) STAT-Check and Medline during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 1 medical devices recalls due to potential defect, including infant/child reduced energy defibrillation electrodes, catheters and more. Additionally, there have been 3 drug and medical device recalls due to other health hazards as well as 100 food recalls.

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SunMed Holdings, LLC , Logo
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Company Contact Information:

Name: SunMed Holdings
Website: www.sun-med.com
Phone: 1-800-433-2797

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Resuscitator Bags

Brand Name(s): STAT-Check, Medline

Reason for Recall: Defect

Official Recall Date: 2018-06-01


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Additional information provided by the FDA.gov:

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date. Read More.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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