FDA recall Z-3107-2017

Product

Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures

Reason for recall

The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

Distribution

Worldwide Distribution - US (Nationwide) and Internationally to Canada

Key facts

Status

Terminated

Initiation date

2017-08-01

Report date

2017-09-13

Termination date

2019-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3107-2017