Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1057-2008 · Posted 2008-04-24