Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (failure to deliver air) where no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Sun Med, LLC is recalling 80 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Bag Reservoir, PEEP Valve, and 7 ft. Oxygen Tubing (Ref CPRM1116P). The affected units are identified by Lot Number 313545. The recall was initiated due to a potential defect where the patient port retaining ring may not fully seat, allowing the patient port to detach during use.
This defect may impact air delivery to the patient. The affected products were distributed to distributors in Illinois and Ohio. The source text does not report any specific injuries or illnesses associated with this recall.
Healthcare providers and consumers should stop using the affected devices and contact Sun Med, LLC for further instructions or a replacement.
The recalled product
- Product
- MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
- Manufacturer
- Sun Med, LLC
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 313545
Distribution
Part of a larger recall action
This product is one of 14 recalled by Sun Med, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Sun Med, LLC
See all →- HighSun Med STAT-Check Manual Resuscitator Recalled for Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- HighSun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
Same hazard · air delivery failure
See all →- HighSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- HighSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20