The Recall Desk
HighFDA (Devices)·Z-2462-2021·Announced 2021-09-22

BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues

CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.

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 FDA Class II device recall addresses potential valve malfunction and therapy delay with no illnesses or injuries reported. It meets the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CAREFUSION is recalling the BD Gravity Burette Set 60 DP 3 SmartSite with needle-free connector valves (Reference: 10012564). The needle-free connector valves may have difficulty flushing, flow issues, or develop partial to total occlusions, which could lead to delays in medication delivery through intravenous therapy.

Approximately 29,130 affected units were distributed worldwide. US distribution includes Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Washington DC, West Virginia, Wisconsin, and Wyoming. International distribution includes Argentina, Australia, Belgium, Brazil, Canada, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.

If the product has already been used or was safely connected to the female luer of the connecting device, no follow-up action is required.

The recalled product

Product
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Manufacturer
CAREFUSION
Category
Medical Device — Intravenous Delivery
Hazard
  • 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: 20026597 20026598 20096477 20106218 20115237 20126022 20126023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category