BD needle-free connector valves may occlude or restrict fluid flow
BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.
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 is a Class II FDA medical device recall with confirmed functional defects (occlusions and flow obstruction) that could delay patient therapy. No illnesses or injuries have been reported, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
CAREFUSION is recalling BD Burette Gravity Set 60 Drop 2 Smartsite needle-free connector valves (Reference 42163E, Lot 21015553) due to identified functional defects. The affected units were distributed worldwide across the United States and internationally.
The needle-free connector valves may experience difficulty flushing, flow issues, and partial or total occlusions. These defects could lead to delays in patient therapy administration.
Patients and healthcare providers should inspect affected valves for signs of improper fluid flow before use. Devices with identified occlusions or flow restrictions should not be used. No follow-up action is required if the product has already been used or was safely connected to the receiving device.
For device replacement or additional information, affected customers should contact CAREFUSION.
The recalled product
- Product
- BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
- Manufacturer
- CAREFUSION
- Hazard
- occlusion
- flow-obstruction
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)
- Lots: 21015553
Distribution
Distributed nationwide across the United States.
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