Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Summary
The FDA issued a Class I for Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manomet by SunMed Holdings, LLC. 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 p.
Details
Source
Device Recall
External ID
Z-1814-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
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
Quantity Affected: 11,358
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.
Distribution
US Nationwide distribution via Medline.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-01
Company
Grand Rapids, MI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SunMed Holdings, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SunMed Holdings, LLC have FDA actions?
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1814-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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