Kimberly-Clark Corporation: Medical Device Recall in 2012 - (Recall #: Z-0257-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 5, 2012

Date Posted: November 14, 2012

Recall Number: Z-0257-2013

Event ID: 63598

Reason for Recall:

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

Status: Terminated

Product Quantity: 89,856 (28 units per case)

Code Information:

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

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated