FDAClass IIJuly 9, 2014

Suture Set recall: Sterility Concern

Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Why was Suture Set recalled?

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

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?

Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.

Product
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Recalling firm
Medical Action Industries Inc
Quantity
474 cs (9,480 ea) total for all kits involved
Distribution
Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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