FDAClass IIIDecember 3, 2014

Non-sterile drape recall: Labeling Error

Non-sterile drape

Why was Non-sterile drape recalled?

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

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?

Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282

Product
Non-sterile drape
Recalling firm
Novadaq Technologies, Inc.
Quantity
324 units
Distribution
Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
Recall date
December 3, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls