STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use

AUDIENCE: Risk Manager, Nursing, Emergency Medicine, Critical Care Medicine

ISSUE: SunMed Holdings 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.

The list of affected lot numbers may be found in the recall notice.

BACKGROUND: A manual resuscitator or "self-inflating bag", is a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately.

RECOMMENDATION: End users who have STAT-Check or Medline resuscitator bags within the lot numbers listed below should stop using them and immediately contact SunMed Holdings or 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 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.

Contact SunMed Holdings with questions via telephone at 1-800-433-2797 or via e-mail at [email protected] between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday.

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
• 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: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609537.htm