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: 26,609 packs (159,657 eaches) Lot/code info: Catalog Number: iAS8-100LP. UDI-DI: 10845854045718. Lot Numbers: 202509034, 202511194, 202509174, 202506264, 202506254, 202506274, 202507074, 202505096, 202507244, 202508124, 202508194, 202507084, 202504294, 202505074, 202504304, 202504155, 202505064, 202505094, 202505204, 202509244, 202511184, 2025102210, 202508254, 2025111110, 202510154, 202508054, 202508114, 202507254, 202509084, 202509054, 202411015, 202408155, 202503016, 202504234, 202505264, 202501134, 202411124, 202501135, 202412195, 202411305, 202511274, 202509274, 202511284, 202504284, 202504224, 202503194, 202504085, 202508184, 202510304, 202409034, 202409095, 202409094, 202408085, 202410104, 202506304, 202506054, 202510094, 202409025, 202410175, 202508264, 202408095, 202408125, 202411115, 202411014, 202506044, 202509194, 202511264, 202408274, 202412205, 202412025, 202501236, 202501235, 202501244, 202503156, 202503145, 202503144, 202504084, 202408094, 202408084, 202410105, 202502066, 202501094, 202509184, 202408275, 202408194, 202507144, 202507154, 202412024, 202501234, 202411295, 202504094, 202503196, 202503125, 202503126, 202503034, 202504145, 202408165, 2025081811, 202408154, 202503264, 202502055, 202411294, 202412106, 202601074, 2026010711, 202501225, 202412204, 202501245, 202409106, 202410315. *OUS added 06/10/2026 expansion:202408284, 202509244, 202507254, 202508054, 202508194, 202505064, 202504294, 202504155, 202504304, 202501085, 202501146, 202501274, 202501224, 202410314, 202410315, 202509034, 2025111110, 2
10845854045718
Official record: FDA (Device enforcement) ↗
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