Home › Device types › BTL
Ventilator, Emergency, Powered (Resuscitator)
FDA product code BTL · Class 2 · Anesthesiology
340
Registered devices
4,757
Adverse events
29
Recalls
100
510(k) clearances
Devices with this code
Life Support Products — Allied Medical, LLCLife Support Products — Allied Medical, LLCAincA — ANESTHESIA ASSOCIATES, INC.BCI — ICU MEDICAL, INC.Life Support Products — Allied Medical, LLCFISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE LIMITEDLife Support Products — Allied Medical, LLCResusa-Tee T-Piece Resuscitator — MERCURY ENTERPRISES, INC.N/A — AirLife Finland OyPneupac — ICU MEDICAL, INC.Giraffe Stand-alone Infant Resuscitation System — Datex-Ohmeda, Inc.FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE LIMITEDNeo-Tee T-Piece Resuscitator — MERCURY ENTERPRISES, INC.Curaplex — BOUND TREE MEDICAL, LLCLife Support Products — Allied Medical, LLCPneupac — ICU MEDICAL, INC.FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE LIMITEDPneupac — ICU MEDICAL, INC.Life Support Products — Allied Medical, LLCPneupac — ICU MEDICAL, INC.Ventrain — Ventinova Medical B.V.AincA® — ANESTHESIA ASSOCIATES, INC.Neo-Tee T-Piece Resuscitator — MERCURY ENTERPRISES, INC.Pneupac — ICU MEDICAL, 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.