Sun Med recalls specific adult manual resuscitators due to risk of patient port detaching during use, potentially affecting air delivery. Affected units have lot numbers 313471, 313627, and : 313696.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Sun Med is recalling adult manual resuscitators with medium adult masks that could detach during use, risking interrupted air delivery to patients. This is a safety issue for healthcare providers using these devices.
The patient port retaining ring might not fully secure, causing the port to detach during use. This could interrupt air delivery to the patient, potentially affecting their breathing.
Healthcare providers using the recalled resuscitators are most at risk. Patients receiving care with these devices could be affected if the port detaches.
Check for lot numbers 313471, 313627, or 313696 on the resuscitator. The product is a Sun Med Adult Manual Resuscitator with medium adult mask, tube reservoir, filter, and 7 ft. oxygen tubing.
Look for lot numbers 313471, 313627, or 313696 on the resuscitator.
The patient port retaining ring might not fully seat, causing the port to detach during use and potentially interrupting air delivery to the patient.
Check the lot number on the resuscitator. If it matches 313471, 313627, or 313696, contact Sun Med for further instructions.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2154-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2154-2018 from Sun Med. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.