Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking chemical exposure, blood loss, or infection.
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, blood loss, and infection.
Plain-English summary
Becton Dickinson & Company is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing (Catalog Number CPA00040). The recall involves 5,296,132 units distributed worldwide. The specific lot numbers affected are REEN0219, REEP1376, and REEP3657.
The recall was initiated because the tubing near the Luer or Y site of the device may develop cracks or breaks. These defects can cause leakage, leading to exposure to chemicals such as chemotherapeutics or biohazard materials like blood. Additionally, cracks or breaks may result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination that could lead to infection.
Healthcare providers and facilities should check their inventory for the affected catalog number and lot numbers. Users should stop using the affected devices and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 5,296,132
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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