ClearanceBrief
Recall Z-2007-2019 ยท FMF Syringe, Piston

Becton Dickinson & Company

3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

DateFeb 1, 2019
StatusTerminated
ReasonThe syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Root causeUnder Investigation by firm
ActionUrgent Medical Device Recall notification letters dated 2/1/19 were sent to customers.
Quantity460,800
DistributionThe products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K980987BECTON DICKINSON SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 11, 1998