Recall: STAT-Check, Medline Resuscitator Bags
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.
Company Contact Information:
Name: SunMed Holdings
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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
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.