—#171031

Product

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

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Lot Number 8303571

Why it was recalled

The 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 cause (FDA determination)

Under Investigation by firm

Action the firm took

Urgent Medical Device Recall notification letters dated 2/1/19 were sent to customers.

Recalling firm

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

Distribution

Distribution pattern: The 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.

Timeline

Recall initiated: 2019-02-01
Terminated: 2020-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.