Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2889-2020Class II

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

Becton Dickinson & Co / initiated 2020-07-28 / Terminated / root cause: manufacturing process

Becton Dickinson & Company began a recall of BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack on . FDA classified it as Class II and gives the reason as "Printed 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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2889-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Product code
FMI Needle, Hypodermic, Single Lumen
Reason for recall
Printed 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 cause tag
manufacturing process
FDA root cause
Equipment maintenance
Action
BD 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.
Quantity in commerce
125,200 units
Distribution
US and Canada
Product codes and lots
Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2889-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2889-2020Class IITerminatedVoluntary: Firm initiated