SunMed Holdings, LLC: Device Recall

Recall Details

Recall Number

Z-1814-2025

Classification

Class I

Product Type

Device

Recalling Firm

SunMed Holdings, LLC

Status

Ongoing

Date Initiated

05/01/2025

Location

Grand Rapids, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11,358

Reason for Recall

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

Product Description

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

Distribution Pattern

US Nationwide distribution via Medline.

Other Recalls by SunMed Holdings, LLC

• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 05/15/2025
  The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

View all recalls by SunMed Holdings, LLC →