FDA recall Z-0960-2019

Abbott Vascular · Class II · device

Product

PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Reason for recall

Incorrect expiration being entered for one lot.

Distribution

US Nationwide Distribution - NC and NY

Key facts

Status
Terminated
Initiation date
2018-07-03
Report date
2019-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Temecula, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2019