The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

Related recalls

Same manufacturer · Sun Med, LLC

See all →

Same hazard · structural defect

See all →