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: 497 packs (2,982 eaches) Lot/code info: Catalog Number: iASB5-150. UDI-DI: 10845854045695. Lot Numbers: 202510144, 202508124, 202501144, 202408144, 202412044, 202505064, 202511284. *OUS added 06/10/2026 expansion: 202408144, 202501144, 202505064, 202508124, 202510144. Manufactured from 14 June 2024 to 12 January 2026.
10845854045695
Official record: FDA (Device enforcement) ↗
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