FDAClass IIMarch 7, 2018

AVID TruCustom SPINE convenience kits recall: Foreign Material

AVID TruCustom SPINE convenience kits, Item Code: LITT016-04

Why was AVID TruCustom SPINE convenience kits recalled?

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

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, Expiration Date: 1211095, 3/1/2018; 1216086, 3/1/2018

Product
AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
Recalling firm
Avid Medical, Inc.
Quantity
30
Distribution
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls