Oxygen masks recalled after complaints of tubing disconnecting during use
Medline is recalling 1,611,081 Hudson RCI medium concentration oxygen masks after multiple complaints of tubing disconnecting, which may lead to shortness of breath and hypoxia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states tubing disconnection may cause shortness of breath and hypoxia requiring intervention, and no injuries are reported.
Plain-English summary
Medline Hudson RCI Medium Concentration Oxygen Masks are being recalled, across the item codes listed in the enforcement record including 1041CE, HUD1035, HUD1042 and HUD1930, covering paediatric and adult versions.
The firm received multiple complaints regarding tubing disconnecting from the oxygen mask. Medline states that if the issue occurs during use, it may lead to a delay in patient care, and the patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
The record lists 1,611,081 eaches, with UDI pairings for each item recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States and to Australia, the Bahamas, Canada, China and the Dominican Republic among other countries. The FDA has classified the action as Class II.
Facilities should follow Medline's instructions.
The recalled product
- Product
- Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Oxygen mask
- Affected units
- 1,611,081
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 (4)
- UDI: 1041CE 00888277446727 (ea) 40888277446725 (case)
- HUD1035 10197344011575 (ea) 20197344011572 (case)
- HUD1042 10197344011544 (ea) 20197344011541 (case)
- HUD1930 10197344009626 (ea) 20197344009623 (case)
Distribution
Distributed nationwide across the United States.
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