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Open, Classified

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

FDA Recall Z-1814-2025 · Posted 2025-05-30

Recalling FirmSunMed Holdings, LLC
Recall StatusOpen, Classified
Product CodeBTM
Date Initiated2025-05-01
Product Quantity11,358

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution via Medline.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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