PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: March 6, 2019 Initiated: July 3, 2018 #Z-0960-2019

Product Description

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.

Details

Recalling Firm
Abbott Vascular
Units Affected
26 units
Distribution
US Nationwide Distribution - NC and NY
Location
Temecula, CA

Frequently Asked Questions

What product was recalled?
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).. Recalled by Abbott Vascular. Units affected: 26 units.
Why was this product recalled?
Incorrect expiration being entered for one lot.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0960-2019.