Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
- Company
- Sunmed Holdings, Llc
- Recall Initiated
- May 1, 2025
- Posted
- May 30, 2025
- Recall Number
- Z-1814-2025
- Quantity
- 11,358
- Firm Location
- Grand Rapids, MI
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.
Distribution
US Nationwide distribution via Medline.
Lot / Code Info
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
Root Cause
Process control
Action Taken
Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed. If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.