medical MODERATE Updated 2025-03-26

Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with -

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Recalled Product

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807.

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Hazard / Issue

Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number and Revision - REF/UDI-DI(Lot): 006147 Rev N - 006324/20884521551692(C210417257, C210957017, C211102266, C211206691, C220108497, D191171644, D191171646, D191176150, D191278690, D200316307, D200538149, D200639546, D200742524, D200745256, D200950569, D200951852, D201055941, D201261296, D210101027, D210103472, D210310524, D210413725, D210726722, D220211210), 10884521551695(D191171644, D191171646, D191176150, D191278690, D200316307, D200745256, D201261296, D210103472); 007738/20884521216010(D191069375, D191171650, D191176156, D200314292, D200431907, D200537959, D200742194, D200745606, D200950373, D201260700, D210308577, D210728936, D211047680, D211155459); 010807/20884521551920(D200101284, D200426597, D200742219, D200745037, D201260710, D210310546, D210837166), 10884521551923(D200101284, D200745037).

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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