FDAClass IIAugust 14, 2013

Non-sterile Viscot Surgical Skin Markers recall: Sterility Concern

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices…

Why was Non-sterile Viscot Surgical Skin Markers recalled?

PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.

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?

Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.

Product
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices…
Recalling firm
Precision Dynamics Corporation
Quantity
1,200 pens
Distribution
US Distribution including the states of SC, TX, TN, WA, OK.
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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