CAGClass IILife-sustaining
Circulator, Breathing-circuit
Anesthesiology · 21 CFR 868.5250
MDR events197All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
197 adverse event reports on file
- PORTEX MANUAL RESUSCITATORJan 13, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v3012307300-2026-00312
- ADULT BI-PAP SINGLE LIMB HEATED WIRE B/S 1.6M (KIT 1)Jun 27, 2024MalfunctionFlexicare Medical Ltd3006061749-2024-00024
- PORTEX ANESTHSIA BREATHING BAG, 3L, 22MMApr 3, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-02003
- PORTEX ANESTHSIA BREATHING BAG, 3L, 22MMApr 2, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-01989
- PORTEX MANUAL RESUSCITATORDec 11, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00011
- PORTEX MANUAL RESUSCITATORDec 1, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00004
- PORTEX MANUAL RESUSCITATORDec 1, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00005
- PORTEX MANUAL RESUSCITATORDec 1, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00006
- PORTEX MANUAL RESUSCITATORDec 1, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00007
- PORTEX MANUAL RESUSCITATORDec 1, 2023MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2023-00008
Event type breakdown
Malfunction187
Injury7
Unspecified1
Death1
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.