Sun Med Recalls Adult Manual Resuscitators Due to Port Retaining Ring Defect
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.
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, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Bag Reservoir, PEEP Valve, CO2, and 7 ft. Oxygen Tubing (Ref CPRM1116PC). The affected units are identified by Lot Number 313235 and were distributed to distributors in Illinois and Ohio.
The recall is due to a potential defect where the patient port retaining ring may not fully seat. This issue could allow the patient port to detach during use, which may impact air delivery to the patient.
Consumers and healthcare facilities 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, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
- Manufacturer
- Sun Med, LLC
- Affected units
- 40
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: 313235
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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