Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
FDA device recall Z-1814-2025 · posted 2025-05-30 · Open, Classified
Recall details
- Recalling firm
- SunMed Holdings, LLC
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTM
- Quantity affected
- 11,358
- Distribution
- US Nationwide distribution via Medline.
- Date initiated
- 2025-05-01
- Date posted
- 2025-05-30
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANUAL PULMONARY RESUSICITATOR (K953546) | Medical Marketing Concepts | 1996-02-29 |