The Recall Desk
HighFDA (Devices)·Z-2457-2021·Announced 2021-09-22

BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay

BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been 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: FDA Class II medical device recall with no reported injuries or hospitalizations. The hazard represents a risk of therapy delay due to valve malfunction, meeting the rubric criterion for Score 3: risk-of-harm product where injury has not yet been reported.

Plain-English summary

BD Syringe Set needle-free connector valves (REF: 10798696, 10798703) with Anti-Siphon SmartSite VLV Sensing Disc are being recalled due to potential valve dysfunction. The valves may experience difficulty flushing, flow issues, or partial to total occlusions that could delay patient therapy.

Approximately 16,700 units have been distributed worldwide, including across all US states and territories, as well as Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil. Affected lot numbers are 20026497, 20025590, 20076421, 21015406, and 21015407.

According to the recall notice, follow-up activations are not required if the product has already been used or was safely connected to the female luer of a connecting device. Patients with these devices should consult their healthcare provider for guidance.

The recalled product

Product
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
Manufacturer
CAREFUSION
Category
Medical Device — Syringe / Infusion Connector
Hazard
  • flow-obstruction
  • valve-malfunction

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: 20026497 20025590 20076421 21015406 21015407

Distribution

Distributed nationwide across the United States.

Related recalls

Same category