Z-0257-2013Class II

ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown...

Name: Z-0257-2013 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown...
Creator: Kimberly-Clark Corporation
Published: 2012-07-05
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2012-07-05 / Terminated / root cause: packaging

FDA source

Kimberly-Clark Corporation began a recall of ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating... on 2012-07-05. FDA classified it as Class II and gives the reason as "Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled". 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-0257-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-05
Posted: 2012-11-07
Terminated: 2013-06-13
Recalling firm: Kimberly-Clark Corporation
Product: ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product 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: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Kimberly Clark sent an Urgent Voluntary Product Recall letter dated July 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to determine if they have any affected product in their inventory. Any affected product should be quarantined and distribution discontinued. Distributors were also asked to conduct a sub-recall for any affected product further distributed. Customers were asked to complete the attached Distributor Product Recall Response Form and fax to 1-920-225-3522. Upon completion of the response form customers were asked to destroy any affected product. For questions regarding this recall call 770-587-7835.
Quantity in commerce: 89,856 (28 units per case)
Distribution: Nationwide Distribution
Product codes and lots: Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0257-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0257-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0258-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07

Product code KKX

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)