Recalls / —
—#171032
Product
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
- FDA product code
- FMI — Needle, Hypodermic, Single Lumen
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K944757
- Affected lot / code info
- Lot Number 8307694
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 #171032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.