BD Cathena IV Catheter Safety Shield May Fail to Properly Engage
Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.
What this means for you
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 FDA Class II recall involves a failure of the safety mechanism on an IV catheter that can result in needle-stick injury and contamination exposure. No illnesses, injuries, or hospitalizations have been reported, so this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson Infusion Therapy Systems Inc. is recalling approximately 98,000 units of the BD Cathena Safety IV Catheter with BD Multiguard Technology (Ref: 386862). The safety shield on these catheters may fail to properly engage, which can allow the needle to pull through and disconnect from the safety shield, leaving the contaminated needle point exposed.
The affected catheters have been distributed nationwide in the United States in the following states: California, Florida, Georgia, Massachusetts, Minnesota, Missouri, Mississippi, New Jersey, Ohio, and Texas. The recalled lot is identified as Lot #2238464 with UDI-DI: (01)00382903868629.
Patients and healthcare providers who suspect they have received or used one of the affected catheters should contact Becton Dickinson for instructions on return or replacement. If a patient was exposed to a needle that failed to be properly shielded, follow standard post-exposure protocols. Healthcare facilities should immediately remove the affected catheters from inventory and discontinue use.
The recalled product
- Product
- REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- needle-stick
- contamination
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 # 2238464/ UDI-DI: (01)00382903868629
Distribution
Distributed nationwide across the United States.
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