Flexicare Medical Ltd.
CYNON VALLEY BUSINESS PARK, RHONDDA CYNON TAFF Wales, GB
Registered product codes
48 product codes
Recent MDR events
137 on file
- PROVU VIDEO LARYNGOCOPEJun 15, 2026InjuryMW5189487
- PROVU VIDEO LARYNGOSCOPEApr 6, 2026InjuryMW5186396
- HIGH FLOW NASAL CANNULA INTERMEDIATE INFANT MAXIMUM 8 LPMFeb 18, 2026Malfunction3006061749-2026-00004
- BRITEBLADE PRO SINGLE-USE FIBER OPTIC MAC 4Jan 7, 2026Malfunction23991329
- PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE WITH HYPER ANGULATED BLADE SIZE 3.5Dec 9, 2025Malfunction3006061749-2025-00061
- PROVUOct 21, 2025Malfunction3006061749-2025-00058
- ADULT ET CLOSED SUCTION CATHETEROct 21, 2025Malfunction3006061749-2025-00059
- PROVUOct 1, 2025Malfunction3006061749-2025-00057
- PROVU REUSABLE 8.0" VIDEO STYLET DISPLAY, CHARGING CABLE AND 2M AMPLIFIER CABLESep 30, 2025Malfunction3006061749-2025-00049
- PROVU REUSABLE LARYNGOSCOPESep 29, 2025Malfunction3006061749-2025-00050
Recalls
5 on file
- TerminatedNov 26, 2020
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
View FDA record ↗ - TerminatedJan 13, 2020
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
View FDA record ↗ - TerminatedJan 13, 2020
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
View FDA record ↗ - TerminatedJan 13, 2020
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
View FDA record ↗ - TerminatedJan 13, 2020
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
View FDA record ↗
Compliance history
Matched by FEI 3006363476.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.