Medical device recalls Moderate risk

Abbott Vascular recalls PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction wit…

Recall date
July 3, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0960-2019
FDA classification
Class II
Brand / firm
Abbott Vascular
Sold / distributed
US Nationwide Distribution - NC and NY

Why it was recalled

Incorrect expiration being entered for one lot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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).

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