FDAClass IIFebruary 7, 2018

9x15" Medium Utility Positioner with Cover recall: Foreign Material

9x15" Medium Utility Positioner with Cover

Why was 9x15" Medium Utility Positioner with Cover recalled?

Products may not meet specifications due to possible presence of metal shavings.

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?

Recorder Code 1400239

Product
9x15" Medium Utility Positioner with Cover
Recalling firm
Molnlycke Health Care, Inc
Quantity
204 units total
Distribution
Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls