Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, 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 potential exposure to hazardous chemicals and risks of serious injury such as air embolism or infection, meeting the criteria for a Severe rating.
Plain-English summary
Becton Dickinson & Company is recalling SafeStep Huber Needle Set myPICK Port Access Kits. The recall covers catalog numbers CPA00020A, CPA00042A, and CPA00049, with a total of 5,296,132 units distributed worldwide.
The recall is due to the potential development of cracks or breaks in the tubing near the Luer or Y site. These defects can cause leakage, exposing users to chemicals such as chemotherapeutics or biohazard materials like blood. Additionally, cracks or breaks could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to infection.
Healthcare providers and facilities should stop using the affected devices and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
- 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 (2)
- Catalog Numbers CPA00020A (UDI 00801741129827)
- CPA00042A (UDI 00801741182969)
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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