ClearanceBrief
Recall Z-1055-2015 ยท FMF Syringe, Piston

Becton Dickinson & Company

BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-

DateFeb 5, 2015 (initiated Dec 19, 2014)
StatusTerminated
ReasonThe stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
Root causeDevice Design
ActionBD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703.
Quantity564,000 units
DistributionUS Nationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K110771BD SINGLE USE, HYPODERMIC SYRINGE
Becton, Dickinson and Company, May 13, 2011
K944931BECTON DICKINSON BLUNT STEEL CANNULA
Bd Becton Dickinson Vacutainer Systems Preanalytic, Aug 29, 1995
K974363BECTON DICKINSON BLUNT PLASTIC CANNULA
Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 3, 1998