Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
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: FDA Class II recall affecting a high-risk neonatal respiratory device where malfunction could cause respiratory failure, hypoxia, or aspiration. Classified as a 'risk-of-harm product where injury has not yet been reported' under the rubric, as no illnesses or injuries have been documented despite serious potential consequences.
Plain-English summary
Microstream Advance neonatal-infant intubated CO2 filter lines are used to monitor carbon dioxide levels in infants receiving mechanical ventilation. The recall affects approximately 704,423 units distributed worldwide, including across all U.S. states and internationally.
The FDA has classified this as a Class II recall because the adapter may be difficult or impossible to disconnect from the endotracheal tube. When disconnection cannot be achieved, healthcare providers may be unable to perform necessary airway procedures such as suctioning.
Difficulty disconnecting the adapter may delay treatment and could result in unintended extubation (accidental removal of the breathing tube). These complications pose risks of respiratory failure, hypoxia, aspiration, and low oxygen saturation in vulnerable neonatal patients.
No deaths, illnesses, or injuries have been reported to the FDA. Healthcare providers using affected devices should contact their institutions' respiratory or biomedical teams for guidance and product verification.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infan
- Manufacturer
- Oridion Medical 1987 Ltd.
- Affected units
- 704,423
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)
- C220650235
- C220858356
- C220865467
- C230417501
- C231048771
- C240417204
- C240522125
- C240624670
- D181134920
- D181134922
- D201159585)
- 10884521761988(C210415594
- C210525057
- C211101243
- C211105839
- C211213507
- C220103340
- C220213101
- C220213102
- C220317965
Distribution
Part of a larger recall action
This product is one of 10 recalled by Oridion Medical 1987 Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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