FDA Cites Kimberly-Clark on Sterilization Wrap

In September, CDRH release a June 4 warning letter to Kimberly-Clark Healthcare accusing it of failing to submit new 510(k)s for modified products that required them.

October 10, 2008

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FDA Cites Kimberly-Clark on Sterilization Wrap

It said the firm marketed models of Kimguard One-Step Simultaneous Sterilization Wrap and Kimguard Sequential Sterilization Wrap after making significant changes to the previously cleared devices.The letter said that changes to critical attributes of a sterilization wrap such as construction, weight, and tensile strength could affect sterilant penetration ability or maintenance of sterility and as a result, the device's safety and efficacy.The letter also said that the company should take prompt action to correct the deviations and respond within 15 days with steps taken to correct the problem and how it plans to prevent such violations from happening again.--James G. Dickinson

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