This device does not indicate for use in patients with respiratory failure.
Reason for recall: This device does not indicate for use in patients with respiratory failure. Distribution: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (H Quantity: 3 units in US 22,416 units and 49 units OUS Lot/code info: BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 1111144M, 1111144L, 1111144V, R1076491, 1111154, R1111143, 1101109, 1109594, 1076540, 1076581, 1076583, 1076582, 1111145, 1076581, ; UDI: 00606959021532, 00606959039308, 00606959039315, 00606959039339, 00606959039346, 00606959039353, 00606959039360, 00606959039384, 00606959039391, 00606959042728, 00606959048744, 00606959048751, 00606959048768, 00606959067530, 00606959067660, 00606959412675, 00606959412699; Serial No. N09765363D900, N097653668EAD, N097653679F24, N10271255612B, N1027125653B0, N102712632E75, N102712654B43, N1027126679D8, N1027126890A6, N10271275529B, N10271282A5EC, N10271287F241, N102712880AB6, N102712891B3F, N10271294D902, N10271297EB99, N10271298136E, N1027129902E7, N102713122828, N1027131996FB, N1027132576FF, N102713374C35, N10271476B6D9, N10271511CC6A, N10271513EF78, N1027151851AB, N1030722442C7, N1030728875DB, N10307291F1C2, N10307295B7E6, N103072986C03, N103073053A22, N1030734886A7, N10307349972E, N10307355449A, N103073656EF2, N10307371310E, N10307375772A, N10307378ACCF, N10307381B2C6, N10307385F4E2, N10307387D7F0, N100865519E81, N10086552AC1A, N10086553BD93, N10086554C92C, N10086555D8A5, N10086556EA3E, N10086557FBB7, N100865580340, N1008655912C9, N10086560A560, N10086561B4E9, N100865628672, N1008656397FB, N10086564E344, N10086566C056, N10086567D1DF, N100865682928, N1008656938A1, N10086571AD31, N100865729FAA, N100865738E23, N10086574FA9C, N10086
00606959021532, 00606959039308, 00606959039315, 00606959039339, 00606959039346, 00606959039353, 00606959039360, 00606959039384, 00606959039391, 00606959042728, 00606959048744, 00606959048751, 00606959048768, 00606959067530, 00606959067660, 00606959412675, 00606959412699
Official record: FDA (Device enforcement) ↗
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