Sun Med recalls adult manual resuscitators with medium adult masks that may detach during use, risking air delivery failure. Affected units include CPRM1126FPC model with lot 313315.
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 may not fully seat, causing the port to detach during use. This could interrupt air delivery to the patient, potentially leading to inadequate ventilation.
Healthcare providers using the recalled resuscitators are most at risk. Patients receiving care with these devices could experience interrupted air delivery.
Check for the model CPRM1126FPC with lot number 313315. The device includes a medium adult mask, tube reservoir, filter, PEEP valve, CO2 indicator, and 7 ft oxygen tubing.
Identify the model number on the device, which should be CPRM1126FPC for affected units.
Confirm the lot number is 313315 to determine if the device is part of the recall.
The recall indicates a potential for the patient port to detach during use, which could interrupt air delivery to patients. However, the remedy is not specified in the record.
Check for the model CPRM1126FPC with lot number 313315. The device includes a medium adult mask, tube reservoir, filter, PEEP valve, CO2 indicator, and 7 ft oxygen tubing.
The recall record does not specify a remedy, so no action is required based on the information provided.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2157-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2157-2018 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.