FDAClass IINovember 14, 2012

ULTRA Fabric Reinforced surgical Gown X-Large Sterile recall

ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and…

Why was ULTRA Fabric Reinforced surgical Gown X-Large Sterile recalled?

Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

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?

Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***

Product
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and…
Recalling firm
Kimberly-Clark Corporation
Quantity
89,856 (28 units per case)
Distribution
Nationwide Distribution
Recall date
November 14, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls