Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where a mechanical failure could impact air delivery to a patient. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Tube Reservoir, Filter, PEEP Valve, CO2, and 7 ft. Oxygen Tubing (Ref CPRM1126FPC). The affected units are identified by Lot Number 313315.
The recall was initiated because there is a potential for the patient port retaining ring to not fully seat. This defect may allow the patient port to detach during use, which could impact air delivery to the patient.
The product was distributed to distributors in Illinois and Ohio. The source text does not specify specific end-user locations or provide instructions for consumers on how to dispose of or return the product.
The recalled product
- Product
- MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
- Manufacturer
- Sun Med, LLC
- Affected units
- 2
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: 313315
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
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