FDA-Device2019-03-06Class II

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).

Abbott Vascular
Hazard

Incorrect expiration being entered for one lot.

Sold states
US Nationwide Distribution - NC and NY
Affected count
26 units
Manufactured in
26531 Ynez Rd, Temecula, CA, United States
Products
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).

Official notice

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

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