—#152300

Product

Eclipse Hypodermic Needle

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K161170
Affected lot / code info: N/A

Why it was recalled

BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.

Root cause (FDA determination)

Device Design

Action the firm took

BD sent a Product Advisory Notice and Business Reply Card dated December 29, 2016 via UPS Ground delivery to their affected customers.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2016-12-20
Terminated: 2018-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.