FDA Device Recall Z-2018-2023

Draeger Medical, Inc. · Telford, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Oxylog 3000 Plus emergency and transport ventilator

Lot / serial / GTIN: Catalog No. 5704811 & 5704813; UDI-DI: 04048675398295; All Serial No.

Quantity: 300 units

Reason for recall

Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.

Recall record

Recall number: Z-2018-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S, Bulgaria, Burkina-Faso, Cambodia, Canada, Cayman Islands, Chile, China, Christmas Island, Columbia, Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Faeroe, Finland, France, French Polynesia, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Macau, Malawi, Malaysia, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, North Korea, Norway, Oman, Pakistan, Panama, Pap. New Guinea, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Sint Maarten, Slovenia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, Utd. Arab. Emirates, Uzbekistan, Vietnam, Yemen, Zambia, and Zimbabwe.
Recall initiated: 2023-06-12
Classified by FDA Center: 2023-07-07
FDA published: 2023-07-19
Recalling firm: Draeger Medical, Inc.
Firm location: Telford, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls