The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2146-2018·Announced 2018-06-20

Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

Sun Med, LLC is recalling 1,742 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 recall is classified as FDA Class II. The hazard involves a structural defect in a life-support device that could lead to a failure in air delivery, posing a significant risk of injury to patients.

Plain-English summary

Sun Med, LLC is recalling 1,742 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Bag Reservoir, and 7 ft. Oxygen Tubing (Reference CPRM1116). The recall involves specific lot numbers: 313298, 313516, 313588, 313589, 313058, 313060, 313125, 313173, 313297, 313714, 313715, and 313774.

The recall was initiated 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 affected units were distributed to distributors in Illinois and Ohio.

Healthcare providers and consumers should stop using the affected devices immediately. Users should check their inventory for the specific reference number and lot numbers listed above. If the device matches the recalled description, it should be removed from service and returned to the distributor or Sun Med, LLC according to their instructions.

The recalled product

Product
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
Manufacturer
Sun Med, LLC
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
1,742

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 (11)

  • Lot Numbers: 313298
  • 313516
  • 313588
  • 313589
  • 313058
  • 313060
  • 313125
  • 313173
  • 313297
  • 313714
  • 313715 & 313774

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 →

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