BD Cathena Safety IV Catheter manufacturing defect hole septum
Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.
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: This is an FDA Class II recall of a medical device with a manufacturing defect that poses a risk of harm (blood exposure, therapy delay) without reported illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported meets the High (3) threshold.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling certain BD Cathena Safety IV Catheter models nationwide and internationally due to a manufacturing defect. The affected products are: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN (REF: 386865); BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC (REF: 386803); and BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN (REF: 386862).
The recalled catheters may have a hole in the septum, which may result in blood leakage from the septum during insertion. This defect may cause blood exposure to healthcare workers or the need for a second IV to be placed, potentially resulting in therapy delay.
Approximately 262,800 units have been distributed. Healthcare facilities and providers using these catheters should stop using them and contact Becton Dickinson for replacement or credit. Patients with questions should consult their healthcare provider.
The recalled product
- Product
- BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Category
- Medical Device — IV Catheter
- Affected units
- 262,800
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)
- REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027
- 386803/0100382903868032/4247809/31-Aug-2027
- 386862/0100382903868629/4237744/31-Aug-2027
Distribution
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