ARCHIVE 2. List of Medical Devices - Notification of Shortages [2022-05-18 to 2022-06-08]
Notice to Reader:
This is an archived list. Please refer to the most current version of this list.
Manufacturers and importers must report shortages and discontinuations of medical devices (or their components, accessories or parts) that will lead to a shortage. They must report medical devices that are on the following list.
Date issued: 2022-05-18
Supersedes: 2022-06-08
Access archived versions of this list.
Category / name of the device
Class I medical devices
- Masks (surgical, procedure or medical masks) - Level 1, 2, 3 (ATSM)
- N95 respirators for medical use
- Gowns (isolation or surgical gowns) - Level 2, 3 and 4
- Blood specimen collection tubes (with or without anticoagulant)
Class II medical devices
- Ventilators (including bi-level positive airway pressure or BiPAP machines)
- Ventilators (including continuous positive airway pressure or CPAP machines)
- Oxygen concentrators
- Aspirators/suction pumps (portable and stationary)
- Laryngoscopes
- Endotracheal tubes
- Medical gloves - examination and surgical (nitrile, vinyl)
- Oxygen delivery devices
- Blood specimen collection tubes packaged in a kit (with or without anticoagulant)
Class III medical devices
- Chest drainage systems
- Ventilators (including bi-level positive airway pressure or BiPAP machines)
- Vital signs monitors
- Anesthesia delivery devices
- Defibrillators
Class IV medical devices
- Defibrillators
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