The Recall Desk
SevereFDA (Devices)·Z-2156-2018·Announced 2018-06-20

Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

Sun Med, LLC is recalling 361 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach 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 recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device that could impact air delivery to a patient is assigned a severity score of 4 (Severe), as it represents a significant risk of harm even without reported injuries.

Plain-English summary

Sun Med, LLC is recalling 361 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Tube Reservoir, Filter, PEEP Valve, and 7 ft. Oxygen Tubing (Ref CPRM1126FP). The affected units are associated with lot numbers 313323, 313355, 313739, 313031, 313093, 313190, and 313272.

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. The agency has classified this as a Class II recall.

The affected products were distributed to distributors in Illinois and Ohio. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed above. Users 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, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
Manufacturer
Sun Med, LLC
Category
Medical Device — Respiratory / Resuscitation
Hazard
Affected units
361

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 (6)

  • Lot Numbers: 313323
  • 313355
  • 313739
  • 313031
  • 313093
  • 313190 & 313272

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

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Same hazard · device detachment

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