Recall Z-1814-2025— SunMed Holdings, LLC

Name: FDA recall Z-1814-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Class I · Ongoing

Class I FDA medical device recall by SunMed Holdings, LLC, initiated 2025-05-01. It names one FDA 510(k) clearance: K953546. Product: Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F. Reason: 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..

Recalling firm: SunMed Holdings, LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-05-01
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K953546 — MANUAL PULMONARY RESUSICITATORMedical Marketing Concepts·cleared 1996-02-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.