FDAFDA · Food and drugs·Recall number Z-2155-2018
MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
Published June 20, 2018 · Recall initiated: May 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sun Med, LLC
- Distributor
- IL & OH distributors
- Lot
- Lot Numbers: 313363 & 313738
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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