Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
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.
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 is classified as FDA Class II and involves a medical device defect that could impact air delivery to a patient, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Bag Reservoir, Filter, CO2, and 7 ft. Oxygen Tubing (Ref CPRM1116FC). The affected units are identified by Lot Numbers 313444 and 313239. 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.
Consumers and healthcare facilities should stop using the affected resuscitators and contact Sun Med, LLC for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
- Manufacturer
- Sun Med, LLC
- Category
- Medical Device — Resuscitator
- Affected units
- 5
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 Numbers: 313444 & 313239
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
- 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