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
- Affected units
- 630
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
Part of a larger recall action
This product is one of 15 recalled by CAREFUSION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · CAREFUSION
See all →- HighBD MaxGuard Extension Set Recalled for Incorrect Expiration Year
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
FDA (Devices) · 2022-09-28
Same hazard · occlusion
See all →- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- HighIV set 490315 recalled over backflow between primary and secondary containers
FDA (Devices) · 2025-12-03
- HighIV set 490067 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490385 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490519 recalled over piggyback backflow and priming occlusion
FDA (Devices) · 2025-12-03