Recall Z-0360-06 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Vapotherm, Inc.
Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
| Date | Jan 19, 2006 (initiated Oct 13, 2005) |
| Status | Terminated |
| Reason | A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners. |
| Root cause | Other |
| Action | Vapotherm, Inc. reportedly notified distributors and institutional end users via subscriber list-serve with newsletters sent on 10/13/05, 10/31/05 and 11/04/05. The notifications addressed the CDC epidemiological study, in which no definitive information on the source of the organism was identified. The notice states that the firm continued to recommend disinfection between patients and adherence to FDA limitations on the re-use of single patient consumables. Subsequently, Vapotherm reported that they had developed an enhanced disinfecting protocol including a recommendation for using higher |
| Quantity | 5092 units |
| Distribution | Products were sold to medical device distributors and end users nationwide and in international markets. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.