FDA recall Z-0783-2018

Avid Medical, Inc. · Class II · device

Product

AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09

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-0783-2018