Recall Z-1210-2019— Becton Dickinson & Company

Name: FDA recall Z-1210-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-28

Class I · Terminated

Class I FDA medical device recall by Becton Dickinson & Company, initiated 2019-02-28, terminated 2020-07-30. It names one FDA 510(k) clearance: K811885. Product: SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696. Reason: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates..

Recalling firm: Becton Dickinson & Company
Classification: Class I
Status: Terminated
Initiated: 2019-02-28
Terminated: 2020-07-30
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K811885 — 30-30-2 700 SYRINGE EXTENSION SETY·cleared 1981-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Reason for recall

Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.