Home › Device types › BTL
Ventilator, Emergency, Powered (Resuscitator)
FDA product code BTL · Class 2 · Anesthesiology
339
Registered devices
4,749
Adverse events
29
Recalls
100
510(k) clearances
Devices with this code
MEDUtrigger — WEINMANN Emergency Medical Technology GmbH + Co. KGResusa-Tee T-Piece Resuscitator — MERCURY ENTERPRISES, INC.VAR (VORTRAN Automatic Resuscitator) — VORTRAN MEDICAL TECHNOLOGY 1, INCPneupac — ICU MEDICAL, INC.Life Support Products — Allied Medical, LLCMACS — AIRON CORPORATIONNeo-Tee T-Piece Resuscitator Circuit — MERCURY ENTERPRISES, INC.Life Support Products — Allied Medical, LLCLow-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET — WEINMANN Emergency Medical Technology GmbH + Co. KGAllied Medical LLC — Allied Medical, LLCCuraplex — BOUND TREE MEDICAL, LLCAllied Medical LLC — Allied Medical, LLCo_two e600 — O-Two Medical Technologies IncFISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE LIMITEDPneupac — ICU MEDICAL, INC.SAVe II+ — Automedx, LLCAincA — ANESTHESIA ASSOCIATES, INC.Life Support Proucts (LSP) — Allied Medical, LLCPortex — ICU MEDICAL, INC.Low-pressurehose assembly, 2m, 02 green DISS/ DISS — WEINMANN Emergency Medical Technology GmbH + Co. KGPortex — ICU MEDICAL, INC.AincA — ANESTHESIA ASSOCIATES, INC.FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE LIMITEDo_two e700 — O-Two Medical Technologies Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-10 | Mercury Enterprises, Inc. dba Mercury Medical | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low |
| 2024-08-30 | Mercury Enterprises, Inc. dba Mercury Medical | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of |
| 2021-07-15 | Smiths Medical ASD Inc. | Two devices were labeled with the same serial number |
| 2020-06-26 | Precision Valve & Automation,Inc | While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this |
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