Becton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.
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 Port Access Kits. The affected catalog numbers are PA-0031G, PA-0031YNG, PA-0032G, and PA-0033G. The recall covers 5,296,132 units that were distributed worldwide.
The recall is due to the potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices with breaks or cracks can cause leakage, resulting in exposure to chemicals such as chemotherapeutics or biohazard material like blood. A crack or break could also result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Healthcare facilities and users should stop using the affected devices and contact Becton Dickinson & Company for further instructions.
The recalled product
- Product
- SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
- Manufacturer
- Becton Dickinson & Company
- 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 (3)
- Catalog Numbers PA-0031G (UDI 00801741085666)
- PA-0031YNG (UDI 00801741085673)
- PA-0032G (UDI 00801741087639)
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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