Sun Med recalls adult manual resuscitators with medium adult masks that may detach during use, risking air delivery failure. Affected units have specific model and lot numbers.
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 that could detach during use, potentially interrupting air delivery to patients. This is a safety issue for healthcare providers using the device.
The patient port retaining ring might not seat properly, causing the port to detach during use. This could interrupt air delivery to patients, potentially affecting their breathing.
Healthcare providers using the recalled resuscitators are most at risk. Patients receiving care with the device could be affected if the port detaches.
Check for the model CPRM1116P with lot number 313545. The product was sold under Sun Med, LLC.
Identify the model number CPRM1116P and lot number : 313545
The recall states there is a potential for the patient port to detach during use, but it does not specify that the device is unsafe if used correctly.
The recall remedy is not specified, so no action is required beyond checking if you have the model and lot number.
Check for the model CPRM1116P with lot number 313545. The product was sold by Sun Med, LLC.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2149-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2149-2018 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.