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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm October 13, 2005
Date Posted January 19, 2006
Recall Status1 Terminated 3 on August 28, 2008
Recall Number Z-0360-06
Recall Event ID 33935
Product Classification Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
Product Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
Code Information All S/Ns of the Vapotherm" Model 2000i are affected.
Recalling Firm/
Manufacturer		 Vapotherm, Inc.
198 Log Canoe Circle
Stevensville MD 21666-2128
For Additional Information Contact Joe Papetti
866-827-6843
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 5092 units
Distribution Products were sold to medical device distributors and end users nationwide and in international markets.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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