CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
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 FDA Class II recall involves a critical respiratory medical device malfunction affecting vulnerable neonatal and pediatric patients. While the potential consequences (respiratory failure, hypoxia, aspiration) are serious, no reported illnesses, injuries, or hospitalizations are documented in the recall notice, placing this in the High category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling CO2 sampling lines and airway adapter devices. The recall affects 7,076 units distributed worldwide, including Microstream Luer Adult-Pediatric Airway Adapters (REF 010989) and Omnistream CO2 Sampling Lines (REF 010991).
These medical devices may be difficult or impossible to disconnect from endotracheal tubes. This disconnection difficulty could prevent healthcare providers from performing necessary procedures such as suctioning, causing treatment delays and potentially resulting in unintended extubation (accidental removal of the breathing tube).
The disconnection problem could lead to serious complications including respiratory failure, hypoxia (low oxygen in the blood), aspiration, and low oxygen saturation. Neonatal, infant, and adult-pediatric patients are at particular risk due to their vulnerable respiratory status.
This is a Class II recall from the U.S. Food and Drug Administration. For more information about affected lot numbers and revision levels, visit the FDA Medical Device Recall database or contact Oridion Medical directly.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- adapter-disconnection
- 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 (6)
- 20884521552033(D200320259)
- 10884521762152(C210845590
- C220975945
- C221193754)
- 010991/10884521554092(D200638964
- D210204584)
Distribution
Distributed nationwide across the United States.
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