Sun Med recalls adult manual resuscitators with medium adult masks that may detach during use, risking air delivery issues. Affected units have specific 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 disrupting air delivery to patients. This recall affects specific lot numbers of the CPRM1116FC model.
The patient port retaining ring may not fully seat, causing the port to detach during use. This could interrupt air delivery to the patient, potentially affecting their breathing.
Healthcare professionals using the recalled resuscitators are most at risk. Patients receiving care with these devices could experience interrupted air delivery.
Check for the model CPRM1116FC with lot numbers 313444 or 313239. The product is a manual resuscitator with a medium adult mask.
Inspect the patient port retaining ring to ensure it seats properly before use.
The model number is CPRM1116FC.
Lot numbers 313444 and 313239.
The recall does not provide a fix; users should check the patient port retaining ring for proper seating.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2148-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2148-2018 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.
