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U.S. Department of Health and Human Services

Class 1 Device Recall Adult Manual Resuscitator

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 Class 1 Device Recall Adult Manual Resuscitatorsee related information
Date Initiated by FirmMay 01, 2025
Date PostedMay 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1814-2025
Recall Event ID 96801
510(K)NumberK953546 
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
ProductAdult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
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
Recalling Firm/
Manufacturer		 SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
For Additional Information ContactJessica Hoke
616-259-8400
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionRecall 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.
Quantity in Commerce11,358
DistributionUS Nationwide distribution via Medline.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTM
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