Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can cause significant injury, including air embolism, infection, and exposure to hazardous materials.
Plain-English summary
Becton Dickinson & Company is recalling the SafeStep Huber Needle Set AllPoints Port Access System. The recall covers specific catalog numbers and lot numbers, with a total of 5,296,132 units distributed worldwide.
The recall is issued because the tubing near the Luer or Y site of the device may develop cracks or breaks. These defects can cause leakage, exposing users to chemicals such as chemotherapeutics or biohazard materials like blood. Additionally, cracks or breaks could lead to blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination that may result in infection.
Healthcare facilities and users should stop using the affected devices and contact Becton Dickinson for instructions on how to return or dispose of the products.
The recalled product
- Product
- SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Needle Sets
- Affected units
- 5,296,132
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 (5)
- Catalog Numbers AN152075 (UDI 00801741119484)
- AN152075G (UDI 00801741119583)
- AN162010 (UDI 00801741119682)
- AN162010G (UDI 00801741119446)
- AN162075 (UDI 00801741119675)
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Becton Dickinson & Company 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.
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