Home › Device types › BTC
Bag, Reservoir
FDA product code BTC · Class 1 · Anesthesiology
936
Registered devices
173
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
AincA® — ANESTHESIA ASSOCIATES, INC.Portex — ICU MEDICAL, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.6000 NDGB — HANS RUDOLPH, INC.Portex — ICU MEDICAL, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.Silicone Reservoir Bag 0.5L (600 040 005GE) — FLEXICARE MEDICAL LIMITEDBAG TEE FOR MXR & STD FLMR — PARKER-HANNIFIN CORPORATION6100 NDGB — HANS RUDOLPH, INC.6005 NDGB — HANS RUDOLPH, INC.Portex — ICU MEDICAL, INC.AincA® — ANESTHESIA ASSOCIATES, INC.Portex — ICU MEDICAL, INC.Breath bag Anest Reus 0.5L — Maquet Critical Care ABMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Portex — ICU MEDICAL, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.RUSCH — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLC6000 NDGB — HANS RUDOLPH, INC.Test lung — Drägerwerk AG & Co. KGaAPortex — ICU MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-05 | Ventlab Corporation | During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly. |
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.