Retiro De Equipo (Recall) de Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.

Recall

33935

Class 1

Z-0360-06

2005-10-13

2006-01-19

Terminated

United States

2008-08-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42761

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.

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 level disinfectants and the use of sterile water in the system. The notification refers consignees to the company website for infection prevention and control resources updates. On 12/20/05, Vapotherm notified their list-serve subscribers that they were recalling 2000i devices to conduct a high level disinfectant protocol with the devices to be returned to end users with newly revised labeling to include recommendation for sterile water use and device components designed to provide humidification within a closed system. On 12/22/05, Vapotherm notified distributors and healthcare practitioners via certified mail flagged 'Urgent'. The firm's notification was reportedly sent to hospital respiratory and infection control departments and advised that other therapies, such as nasal CPAP and standard oxygen therapies should be considered during the recall. The notification directs users to the firm's website where users may log on and obtain return authorization for shipping back to the recalling firm. A response form is included with the notification and users are requested to fax back for confirmation of notification.