3B Medical Oxygen Cannula Recall: Units Shipped After Expiration Date
3B Medical recalled 5,010 Ultrasoft Oxygen Cannula units (Model O2U2012, Lot 20170403) distributed in Massachusetts and Arkansas because they were shipped after their expiration date.
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: FDA Class II medical device recall with no reported illnesses or injuries. Expired oxygen cannulas qualify as 'risk-of-harm products where injury has not yet been reported' per the Score 3 rubric criterion, as devices past their expiration date may not function safely.
Plain-English summary
3B Medical, Inc. is recalling 5,010 units of the Ultrasoft Oxygen Cannula, 12 Foot (Model O2U2012, Lot 20170403). The devices were inadvertently shipped after their expiration date.
The recalled cannulas are nasal tubes used with oxygen concentrators. They were distributed in Massachusetts and Arkansas.
Patients and healthcare providers with cannulas from this lot should contact 3B Medical, Inc. to obtain a replacement or for further guidance.
The recalled product
- Product
- Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
- Manufacturer
- 3B Medical, Inc.
- Hazard
- Affected units
- 5,010
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 (1)
- Lot Code: Lot Number 20170403
Distribution
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