Home › Device types › BTC
Bag, Reservoir
FDA product code BTC · Class 1 · Anesthesiology
917
Registered devices
171
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
RUSCH — TELEFLEX INCORPORATEDBREATHING BAG — King Systems CorporationPortex — ICU MEDICAL, INC.Vital Signs™ — AirLife Finland OyAMSure® Universal Cuff Adaptor — AMSINO INTERNATIONAL, INC.Portex — ICU MEDICAL, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.RUSCH — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.6030 NDGB — HANS RUDOLPH, INC.Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd.Portex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.RUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.n.a. — VBM Medizintechnik GmbHPortex — ICU MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Bag, Breathing, 1-Liter Latex Free — A-M SYSTEMS, LLCPortex — 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.