Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for devices that may prevent users from disconnecting them when medically necessary, risking serious complications including respiratory failure and hypoxia. No illnesses or injuries have been reported. The serious potential harm to vulnerable patient populations justifies High severity.
Plain-English summary
The FDA is recalling Microstream CO2 sampling lines and airway adapters manufactured by Oridion Medical 1987 Ltd. This recall affects multiple product variants and models, including FilterLine Sets and VitaLine Sets designed for patient use in clinical settings. Approximately 5.1 million units have been distributed worldwide, including throughout the United States.
These devices may be difficult or impossible to disconnect from endotracheal tubes (breathing tubes) during clinical procedures such as suctioning. When users cannot disconnect the adapter as needed, this may cause treatment delays or unintended extubation (accidental removal of the breathing tube).
Inability to disconnect could lead to respiratory failure, hypoxia (low blood oxygen), or aspiration in affected patients. These complications can develop rapidly and require immediate medical attention.
Healthcare providers currently using these devices should contact their facility management and Oridion Medical for instructions. Facilities should identify affected lots using the product information provided and follow their healthcare system's protocols for managing patients currently using these devices.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- disconnection-difficulty
- respiratory-failure
- hypoxia
- aspiration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- C211105048
- C211195967
- C220103407
- D191067290
- D191176261
- D191280252
- D191283149
- D200101321
- D200424621
- D200430274
- D200432060
- D200434623
- D200537510
- D200949677
- D200952336
- D201261089
- D210101553
- D210102181
- D210204904
- D210310618
Distribution
Distributed nationwide across the United States.
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