In-Line Ventilator Adaptor Recall: Risk of Reduced Oxygenation or Barotrauma
Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall. According to the severity rubric, FDA Class I recalls must score at least 4 (Severe) per the guidance, regardless of reported illnesses.
Plain-English summary
Baxter Healthcare Corporation is recalling 259 in-line ventilator adaptor units (Model M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492, manufacturing dates February 28, 2020 to present).
The adaptor presents a potential risk of reduced oxygenation, pneumothorax, or barotrauma when used with Volara systems in home care environments. This is a Class I recall. No illnesses or injuries have been reported.
The affected adaptor units were distributed nationwide across 33 states.
The recalled product
- Product
- In-Line ventilator adaptor
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 259
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 (3)
- M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT
- UDI-DI: 00887761981492. Manufacturing dates February 28
- 2020 to present.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation 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 2 products in this recall →Related recalls
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See all →- SevereBaxter ventilator adaptor recalled for potential oxygenation failure and barotrauma risk
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