June 5, 2018

FDA: Recall of STAT-Check and Medline manual resuscitator bags

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags.

The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port to detach during use. If the port detaches, the bag may not deliver air to the patient and could result in life-threatening consequences.

The recalled bags were distributed between February 1 and May 13, 2018.

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