Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
Sun Med, LLC is recalling 55 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could impact air delivery to a patient, meeting the criteria for a Severe rating.
Plain-English summary
Sun Med, LLC is recalling 55 cases of Medline Adult Manual Resuscitators with Medium Adult Mask 5, Bag Reservoir, PEEP Valve, and 7 ft. Oxygen Tubing (Ref CPRM1116PD5). The affected units are identified by Lot Numbers 313326, 313436, and 313049. The recall was initiated because there is a potential for the patient port retaining ring to not fully seat, which could allow 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 U.S. Food and Drug Administration has classified this recall as Class II.
Consumers and healthcare providers 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 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
- Manufacturer
- Sun Med, LLC
- Category
- Medical Device — Resuscitator
- Affected units
- 55
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 (2)
- Lot Numbers: 313326
- 313436 & 313049
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
- HighSun Med Recalls Medline 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
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- Severe
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