FDA recall Z-0793-2018

Product

AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04

Reason for recall

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Distribution

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

Key facts

Status

Terminated

Initiation date

2017-06-22

Report date

2018-03-07

Termination date

2018-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0793-2018