The Recall Desk
HighFDA (Devices)·Z-2666-2020·Announced 2020-07-29

Becton Dickinson Recalls SafeStep Huber Needle Set Port Access Kits

Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.

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: The recall is classified as FDA Class II and involves a risk of serious harm (air embolism, infection, exposure to hazardous chemicals) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling SafeStep Huber Needle Set Port Access Kits due to a potential defect in the tubing. The recall involves 5,296,132 units distributed worldwide. The affected catalog numbers include PA-0029, PA-0029YN, PA-0030, PA-0030YN, PA-0031, PA-0031YN, PA-0032, PA-0032YN, PA-0033, PA-0033YN, PA-0034, PA-0034YN, PA-0036, PA-0038, and PA-0038YN.

The recall is issued because cracks or breaks may develop in the tubing near the Luer or Y site of the device. If the tubing breaks or cracks, it can cause leakage, exposing users to chemicals such as chemotherapeutics or biohazard materials like blood. Such failures could also result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to 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 recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-00
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Infusion / IV Accessories
Hazard
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 (14)

  • Catalog Numbers PA-0029 (UDI 00801741085482)
  • PA-0029YN (UDI 00801741085499)
  • PA-0030 (UDI 00801741085505)
  • PA-0030YN (UDI 00801741085512)
  • PA-0031 (UDI 00801741085529)
  • PA-0031YN (UDI 00801741085536)
  • PA-0032 (UDI 00801741085543)
  • PA-0032YN (UDI 00801741085550)
  • PA-0033 (UDI 00801741085567)
  • PA-0033YN (UDI 00801741085574)
  • PA-0034 (UDI 00801741085581)
  • PA-0034YN (UDI 00801741085598)
  • PA-0036 (UDI 00801741085604)
  • PA-0038 (UDI 00801741085628)

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.

See all 12 products in this recall →

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