FDA (Devices) recall action 80201
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sun Med, LLC is recalling STAT-Check Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.
Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.
Sun Med, LLC is recalling 55 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery.
Sun Med, LLC is recalling 1,742 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.
Sun Med, LLC is recalling 30 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.
Sun Med, LLC is recalling 80 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially causing the port to detach and impacting air delivery.
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.
Sun Med, LLC is recalling 361 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.
Sun Med, LLC is recalling 110 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery to the patient.
Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators because a retaining ring may not seat fully, allowing the patient port to detach and impact air delivery.
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.
Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching during use and impacting air delivery.
Sun Med, LLC is recalling 113 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.
Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.