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Terminated

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

FDA Recall Z-2007-2019 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2019-02-01
Date Terminated2020-06-11
Product Quantity460,800

Reason for Recall

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.

Firm Action

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

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980987BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1998-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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