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: 55,694 packs (344,166 eaches) Lot/code info: Catalog Number: iAS8-120LP. UDI-DI: 10845854045657. Lot Numbers: 202503274, 202503314, 202504254, 2025100710, 2025092210, 2025100810, 2025092610, 202510164, 202511204, 2025102410, 2025111210, 202506124, 202506136, 202506164, 202507234, 202507104, 202507114, 202509054, 202407054, 202410245, 202409196, 202503185, 202408295, 202407084, 202501084, 202511285, 202511214, 202412185, 202501175, 202505134, 202502226, 202406185, 202407255, 202407044, 202406195, 202510174, 202508204, 202507094, 202411154, 202410185, 202407175, 202411044, 202411155, 202508114, 202506115, 202505124, 202508234, 202406265, 202501204, 202501226, 202501275, 202505214, 202511244, 202410305, 202409205, 202409206, 202507014, 202505314, 202509044, 2025082510, 202502204, 2025112610, 202502065, 202508194, 202504244, 202407155, 202409194, 202407034, 202410294, 202411065, 202407154, 202508084, 202506304, 2025100610, 2025102710, 2025111410, 202503284, 202407025, 202407225, 202408205, 202409065, 202407234, 202510304, 202508064, 202508074, 202506134, 202411055, 202505264, 202508214, 2025111310, 2025090410, 202511284, 202510204, 202410214, 202501256, 202407115, 202406254, 202409044, 202504284, 202501284, 202503264, 202407235, 202410304, 202505304, 202509264, 202411145, 202410184, 202501074, 202407264, 2025090210, 202507224, 202410215, 202409064, 202511014, 2025082310, 202507264, 202511224, 202509254, 2025091910, 2025101310, 202407055, 202407185, 202505224, 202502104, 202501215, 202410225, 202502286, 202501285, 202504114,
10845854045657
Official record: FDA (Device enforcement) ↗
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