Recall of SunMed Holdings, LLC STAT-Check and Medline Manual Resuscitator Bags

PUBLISHED: Jun 1, 2018
Relevant to: All Healthcare Organizations

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.

End users who have STAT-Check or Medline resuscitator bags within the lot numbers listed in the recall notice, link below, should stop using them and immediately contact SunMed Holdings, LLC for further instructions on the return of these products.

The recalled products were distributed nationwide and can be identified by the part number, description, and lot number on the case labels, as well as a label on the individual packaging bag.

SunMed Holdings, LLC notified its distributors and these distributors have notified their customers by a direct mailing and will arrange for the return and replacement of all recalled resuscitator bags listed above.

End Users with questions may contact SunMed Holdings, LLC via telephone at 1-800-433-2797 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. End Users may also contact SunMed Holdings, LLC via e-mail at info@sun-med.com.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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