ClearanceBrief
Recall Z-2889-2020 ยท FMI Needle, Hypodermic, Single Lumen

Becton Dickinson & Company

BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack

DateJul 28, 2020
StatusTerminated
ReasonPrinted scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Root causeEquipment maintenance
ActionBD Sent a customer letter dated 28 July 2020. this letter requests customers to review their inventory for effected lots and Destroy all product subject to the recall. The letter requests customers to return the included response form and notify BD of any adverse events associated to this product.
Quantity125,200 units
DistributionUS and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K951254SAFETYGLIDE NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 7, 1995