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FDAFDA · Food and drugs·Recall number Z-1581-2017

Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn

Published April 5, 2017 · Recall initiated: January 9, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Resource Optimization & Innovation Llc
Distributor
US Distribution to LA and TX.
Lot
027502C Exp Date 2017-08-17;
Risk classification
Class II
Area (FDA)
device
Country
United States

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