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Terminated

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.

FDA Recall Z-0257-2013 · Posted 2012-11-07

Recall StatusTerminated
Product CodeKKX
Date Initiated2012-07-05
Date Terminated2013-06-13
Product Quantity89,856 (28 units per case)

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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