Z-2425-2012Class III

ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric...

Name: Z-2425-2012 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric...
Creator: Kimberly-Clark Corporation
Published: 2010-12-31
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2010-12-31 / Terminated / root cause: packaging

FDA source

Kimberly-Clark Corporation began a recall of ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical... on 2010-12-31. FDA classified it as Class III and gives the reason as "The impacted product was not intended for commercial distribution to end users". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2425-2012
Classification: Class III
Status: Terminated
Initiated: 2010-12-31
Posted: 2012-09-20
Terminated: 2012-11-01
Recalling firm: Kimberly-Clark Corporation
Product: ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: The impacted product was not intended for commercial distribution to end users.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product according to their facility procedures. And to review their distribution records to identify all customers who were shipped any of the impacted products. Notify each of their customers who were shipped any of the impacted products by sending them a copy of the attached Customer Letter with the Customer Withdrawal Response Form. A minimum of three (3) attempts to contact each non-responding customer within interval of approximately four to six weeks will be performed. Once all customers who were notified have responded or after approximately four weeks after the third attempt to contact the last non-responder, a recall Termination will be initiated If your Kimberly-Clark Representative has not already contacted you, please contact the Ultra Fabric Reinforce surgical Gown Coordinator at (770) - 587-7700.
Quantity in commerce: 32 cases
Distribution: US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Product codes and lots: Product Code: 95221-35, Unit Code: 90372

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2425-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2425-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code KKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)