Potential for overpressure alerts.
Reason for recall: Potential for overpressure alerts. Distribution: Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND Quantity: 71,151 packs (426,908 eaches) Lot/code info: Catalog Number: iAS12-120LPI. UDI-DI: 10845854045688. Lot Numbers: 202506164, 202507144, 202506274, 202506136, 202506124, 2025071010, 202507114, 202506244, 202505194, 202505164, 202505064, 202505144, 202509114, 202508204, 202509124, 202510184, 202509274, 202511064, 202509254, 202509264, 202510254, 202510274, 202508294, 202509104, 202508214, 202509154, 202508084, 202507264, 202507254, 2025080611, 202507284, 202512124, 202511204, 202511214, 202511244, 202512134, 2025100310, 202510034, 202510154, 202511065, 202511075, 202511074, 202510244, 202510174, 202502214, 202503204, 202503075, 202503064, 202504244, 202504025, 2025040310, 2025040411, 202504046, 202503215, 202503244, 202504044, 202501164, 202501244, 202501235, 202506134, 202406204, 202406245, 202408154, 202502194, 202501145, 202505054, 202504036, 202412134, 202501274, 202408095, 202407316, 202410305, 202410244, 202506254, 202508274, 202509244, 202410234, 202411045, 202409035, 202407106, 202506304, 202512104, 202510204, 202501225, 202406214, 2025040210, 2025042110, 2025080810, 202508264, 202408135, 202410315, 202410295, 202408214, 202408294, 202507234, 202505304, 202505294, 202407155, 202408204, 202408206, 202406195, 202503065, 202502244, 202501095, 202504305, 202511086, 2024111911, 202501144, 2025110410, 2025110510, 202510164, 202511104, 2025122310, 202504304, 202501166, 202502184, 202407104, 202406215, 202406206, 202506264, 202410255, 202508284, 202507244, 202408015, 202505154, 202407305, 202411236, 2024112210, 202412105, 2
10845854045688
Official record: FDA (Device enforcement) ↗
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