The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2153-2018·Announced 2018-06-20

Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

Sun Med, LLC is recalling 113 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

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 explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the risk of structural failure impacting air delivery.

Plain-English summary

Sun Med, LLC is recalling 113 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Tube Reservoir, CO2, and 7 ft. Oxygen Tubing (Ref CPRM1126C). The affected units are identified by Lot Numbers 313321, 313437, 313080, and 313193. 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.

Healthcare providers and facilities that have purchased these specific units should stop using them and contact Sun Med, LLC for instructions on how to return or replace the affected products.

The recalled product

Product
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
Manufacturer
Sun Med, LLC
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
113

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: 313321
  • 313437
  • 313080 & 313193

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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