Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1814-2025

May 01, 2025

Class I

Product summary

Firm
SunMed Holdings, LLC
Event
Event 96801
Status
Ongoing
Classification
Class I
Quantity
11,358
Official record key
device-enforcement:Z-1814-2025

Official wording

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.

Code information: UDI-DI: EA: 10884389164822 CS: 40884389164823 Lots: 526782 526790 526796 526797 526798 526800 526802 526804 526805 526806 526807 526808 526809 526810 526814 526815 526816 526811 526817 526818

Distribution pattern: US Nationwide distribution via Medline.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.