—#182707

Product

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K951254
Affected lot / code info: Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240

Why it was recalled

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 (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US and Canada

Timeline

Recall initiated: 2020-07-28
Terminated: 2021-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.