FDA recall Z-3116-2017

Product

BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging

Reason for recall

Presence of loose polypropylene foreign matter above release specification.

Distribution

US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.

Key facts

Status

Terminated

Initiation date

2017-06-13

Report date

2017-09-20

Termination date

2020-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3116-2017