Adult Manual Resuscitator with Medium Adult Mask recalled nationwide
SunMed Holdings is recalling 11,358 Adult Manual Resuscitators because the filter may be incorrectly attached to the patient port instead of the exhalation port, risking interruption or delay in patient resuscitation that could cause serious harm or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall. The source explicitly identifies life-threatening consequences including death as possible outcomes. Class I recalls combined with potential for death trigger a Critical (5) rating per the rubric.
Plain-English summary
SunMed Holdings, LLC is recalling the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing (REF CPRM1116F). A total of 11,358 units were distributed nationwide via Medline.
The affected units were manufactured with the B/V Filter incorrectly attached to the wrong port. Instead of being attached to the exhalation port, the filter was attached to the patient port. If this defect is not noticed before the device is used on a patient, it could interrupt or delay patient resuscitation.
If resuscitation is interrupted or delayed, patients may experience life-threatening consequences including hypoxia, hypercapnia, organ failure, and death.
Affected lot numbers are: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 526807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, and 526818. The product UDI-DI is EA: 10884389164822 and CS: 40884389164823. If you have one of these devices, contact SunMed Holdings or your supplier immediately.
The recalled product
- Product
- Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
- Manufacturer
- SunMed Holdings, LLC
- Affected units
- 11,358
Distribution
Distributed nationwide across the United States.
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