FDAClass IINovember 11, 2015

Regard Custom Surgical Pack recall

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use…

Why was Regard Custom Surgical Pack recalled?

The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 25787E, exp. date 1/19/2017

Product
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use…
Recalling firm
Resource Optimization & Innovation Llc
Quantity
255 packs
Distribution
Product was distributed to one customer in Oklahoma.
Recall date
November 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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