The Recall Desk
HighFDA (Devices)·Z-2463-2021·Announced 2021-09-22

BD Gravity IV needle-free connector valve occlusion risk

BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.

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: This is an FDA Class II medical device recall. Although the hazard—occlusion and flow obstruction leading to therapy delay—poses a risk of patient harm, the source text reports no documented injuries, hospitalizations, or deaths. Per the severity rubric, this constitutes a risk-of-harm product with no reported injury.

Plain-English summary

BD Gravity IV needle-free connector valves are being recalled. The affected models include the 3-port Closed Manifold Back Check Valve with 3 Needle-Free Y-sites (REF: CM42500E-07), the 3-port Closed Stopcock Manifold Back Check Valve with 2 Needle-Free Y-sites (REF: CS42522E-07), and the GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK with 4 SmartSite Valves (REF: 42407E-05). The recall includes 24,360 units manufactured by CareFusion.

These needle-free connector valves may experience difficulty flushing, flow issues, and partial or total occlusions. These problems could lead to therapy delay for patients requiring IV infusion.

The affected products were distributed worldwide, including throughout the United States and to Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil. The recall affects specific lot numbers: 20025968, 20026013, 20035834, 20035835, 20026132, 20026133, and 20085151.

Customers and healthcare providers in possession of affected units should discontinue use and contact CareFusion for further instructions. Follow-up action is not required if the product has already been used or was safely connected to the female luer of the connecting device.

The recalled product

Product
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & Smar
Manufacturer
CAREFUSION
Category
Medical Device — IV Administration
Hazard
  • occlusion
  • flow-obstruction
  • therapy-delay

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 (1)

  • Lots: 20025968 20026013 20035834 20035835 20026132 20026133 20085151

Distribution

Distributed nationwide across the United States.

Related recalls

Same category