Agency classClass IIOur severity:Severe FDA (Devices)·Z-2152-2018·Announced 2018-06-20

Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use 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 source text identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a structural failure that could impact critical air delivery to a patient.

Plain-English summary

Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Tube Reservoir, and 7 ft. Oxygen Tubing (Ref CPRM1126). The affected units are identified by Lot Numbers 313546, 313717, 313176, and 313772. These products were distributed to distributors in Illinois and Ohio.

The recall is being issued 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 U.S. Food and Drug Administration has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected units immediately. Consumers and medical professionals should check their inventory for the specific lot numbers listed above and contact Sun Med, LLC for instructions on returning or replacing the devices.

The recalled product

Product: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
Manufacturer: Sun Med, LLC
Category: Medical Device — Resuscitation Equipment
Hazard: structural-defect
air-delivery-failure
Affected units: 350

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 (3)

Lot Numbers: 313546
313717
313176 & 313772

Distribution

Distributed in 2 states:

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 →

Same manufacturer · Sun Med, LLC

See all →

High
Sun Med STAT-Check Manual Resuscitator Recalled for Port Detachment Risk
FDA (Devices) · 2018-06-20
Severe
Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
Severe
Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
High
Sun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
High
Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20

Same hazard · structural defect