Sun Med recalls adult manual resuscitators with potential air delivery failure due to patient port detachment. Affected models include CPRM1116F with lot 313238. No remedy specified in recall notice.
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 may detach during use, risking air delivery failure to patients. This could lead to inadequate breathing support for medical emergencies.
The patient port retaining ring may not fully seat, causing the port to detach during use. This can interrupt air delivery to the patient, potentially leading to inadequate breathing support during medical emergencies.
Healthcare professionals using the recalled resuscitators are most at risk. Patients receiving emergency care with these devices could experience breathing difficulties.
Check for the model CPRM111:1116F with lot number 313238. This resuscitator includes a medium adult mask, bag reservoir, filter, and 7 ft oxygen tubing.
Identify the model number on the device, which should be CPRM1116F with lot number 313238.
The recall notice does not specify any remedy or fix for this issue.
The recall notice does not provide specific action steps for affected users.
Check for the model CPRM1116F with lot number 313238. This resuscitator includes a medium adult mask, bag reservoir, filter, and 7 ft oxygen tubing.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2147-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2147-2018 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.
