FDAClass IIApril 8, 2015

Smoke Evacuation Tubing Set for Coherent CPG Handpiece recall

Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The…

Why was Smoke Evacuation Tubing Set for Coherent CPG Handpiece recalled?

This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

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 Numbers: C11020, C11129, C11238, C11276, C12013, C12044, C12079, C12094, C12108, C12124, C12212, C12236, C12243, C12254, C12271, C12334, C13031, C13070, C13080, C13162, C13168, C13189, C13205, C13254, C13294, C13345, C14020, C14055, C14072, C14120

Product
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The…
Recalling firm
Microtek Medical Inc
Quantity
303 units
Distribution
US (nationwide) Distribution.
Recall date
April 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls