The Recall Desk
HighFDA (Devices)·Z-2669-2020·Announced 2020-07-29

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, potentially causing leakage of hazardous chemicals 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 involves a medical device with a risk of serious harm (air embolism, infection, exposure to hazardous materials) but the source text does not report any actual injuries or illnesses, 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 Sets with Y Injection Site and Medegen Needleless Injection Cap. The recall involves 5,296,132 units distributed worldwide. The affected products are identified by specific catalog numbers and lot numbers listed in the official recall notice.

The recall is due to the potential development of cracks or breaks in the tubing near the Luer or Y site of the device. If the tubing breaks or cracks, it 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 for instructions on how to return or dispose of the products. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 008
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Infusion/Injection
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 (11)

  • Catalog Numbers LH-0029YN (UDI 00801741066177)
  • LH-0030YN (UDI 00801741066191)
  • LH-0031YN (UDI 00801741066214)
  • LH-0032YN (UDI 00801741066238)
  • LH-0033YN (UDI 00801741066252)
  • LH-0034YN (UDI 00801741066276)
  • LH-0035YN (UDI 00801741066290 )
  • LH-0036YN (UDI 00801741066313)
  • LH-0037YN (UDI 00801741066337)
  • LH-0038YN (UDI 00801741066351)
  • LH-0039YN (UDI 00801741066313)

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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