Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, WF21158, WF21391, WF21165, WF21166, WF21168, WF21169, WF21170, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186, WF21187, WF21188, WF21189, WF21190, WF21192, WF21193, WF21194, WF21195, WF21196, WF21197, WF21198, WF21199, WF21200, WF21201, WF21202, WF21203, WF21204, WF21205, WF21206, WF21207, WF21208, WF21209, WF21210, WF21211, WF21212, WF21213, WF21214, WF21215, WF21217, WF21218, WF21219, WF21220, WF21221, WF21222, WF21223, WF21224, WF21225, WF21226, WF21227, WF21228, WF21229, WF21230, WF21231, WF21232, WF21233, WF21234, WF21235, WF21236, WF21237, WF21238, WF21239, WF21240, WF21241, WF21242, WF21243, WF21244, WF21245, WF21246, WF21247, WF21248, WF21249, WF21250, WF21251, WF21252, WF21253, WF21254, WF21255, WF21256, WF21257, WF21258, WF21259, WF21260, WF21261, WF21262, WF21263, WF21264, WF21265, WF21266, WF21267, WF21268, WF21269, WF21270, WF21271, WF21272, WF21273, WF21274, WF21275, WF21276, WF21277, WF21278, WF21279, WF21280, WF21281, WF21282, WF21283, WF21284, WF21285, WF21286, WF21287, WF21288, WF21289, WF21290, WF21291, WF21292, WF21293, WF21294, WF21295, WF21296, WF21297, WF21298, WF21299, WF21300, WF21301, WF21302, WF21303, WF21304, WF21305, WF21306, WF21307, WF21308, WF21309, WF21310, WF21311, WF21312, WF21313, WF21314, WF21315, WF21316, WF21317, WF21318, WF21319, WF21320, WF21321, WF21322, WF21323, WF21324, WF21325, WF21326, WF21327, WF21328, WF21329, WF21330, WF21331, WF21332, WF21333, WF21334, WF21335, WF21336, WF21337, WF21338, WF21339, WF21340, WF21341, WF21342, WF21343, WF21344, WF21345, WF21346, WF21347, WF21348, WF21349, WF21350, WF21351, WF21352, WF21353, WF21354, WF21355, WF21356, WF21357, WF21358, WF21359, WF21360, WF21361, WF21362, WF21363, WF21364, WF21365, WF21366, WF21367, WF21368, WF21369, WF21370
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Percussionaire Corporation
- Reason for Recall:
- Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Product Codes/Lot Numbers:
UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, WF21158, WF21391, WF21165, WF21166, WF21168, WF21169, WF21170, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186, WF21187, WF21188, WF21189, WF21190, WF21192, WF21193, WF21194, WF21195, WF21196, WF21197, WF21198, WF21199, WF21200, WF21201, WF21202, WF21203, WF21204, WF21205, WF21206, WF21207, WF21208, WF21209, WF21210, WF21211, WF21212, WF21213, WF21214, WF21215, WF21217, WF21218, WF21219, WF21220, WF21221, WF21222, WF21223, WF21224, WF21225, WF21226, WF21227, WF21228, WF21229, WF21230, WF21231, WF21232, WF21233, WF21234, WF21235, WF21236, WF21237, WF21238, WF21239, WF21240, WF21241, WF21242, WF21243, WF21244, WF21245, WF21246, WF21247, WF21248, WF21249, WF21250, WF21251, WF21252, WF21253, WF21254, WF21255, WF21256, WF21257, WF21258, WF21259, WF21260, WF21261, WF21262, WF21263, WF21264, WF21265, WF21266, WF21267, WF21268, WF21269, WF21270, WF21271, WF21272, WF21273, WF21274, WF21275, WF21276, WF21277, WF21278, WF21279, WF21280, WF21281, WF21282, WF21283, WF21284, WF21285, WF21286, WF21287, WF21288, WF21289, WF21290, WF21291, WF21292, WF21293, WF21294, WF21295, WF21296, WF21297, WF21298, WF21299, WF21300, WF21301, WF21302, WF21303, WF21304, WF21305, WF21306, WF21307, WF21308, WF21309, WF21310, WF21311, WF21312, WF21313, WF21314, WF21315, WF21316, WF21317, WF21318, WF21319, WF21320, WF21321, WF21322, WF21323, WF21324, WF21325, WF21326, WF21327, WF21328, WF21329, WF21330, WF21331, WF21332, WF21333, WF21334, WF21335, WF21336, WF21337, WF21338, WF21339, WF21340, WF21341, WF21342, WF21343, WF21344, WF21345, WF21346, WF21347, WF21348, WF21349, WF21350, WF21351, WF21352, WF21353, WF21354, WF21355, WF21356, WF21357, WF21358, WF21359, WF21360, WF21361, WF21362, WF21363, WF21364, WF21365, WF21366, WF21367, WF21368, WF21369, WF21370
Distribution:
Distributed in: US, CA, ND, MS, MD
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0259-2024
Related Recalls
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.