Patient skin preparation product labels updated based on FDA recommendations – Help

The U.S. Food and Drug Administration (FDA) has requested that companies voluntarily make updates to their skin antiseptic products. This request was the result of infrequent reports of infections caused by contaminated skin preparation products.

In response to this industry-wide request initiated by the FDA, BD updated the labels on its ChloraPrep™ patient preoperative skin preparation portfolio in March 2015. We are now updating the remainder of the skin preparation product portfolio labels with information intended to ensure continued clinician education and patient safety.

BD is in the process of updating its product labels by:

Adding the phrase "non-sterile solution" on the label of all products indicated for preoperative skin prep
Including the phrase "single-use" for all products indicated for preoperative skin preps
Removing the phrase "patient preoperative skin preparation" or "preinjection skin preparation" on multiple-use containers

The same antisepsis solution

Our skin preparation products have not changed in any way and continue to be a broad portfolio of antiseptic solutions. For a full list of the affected products, see the enclosed file and its chart of products and their associated updates.

See the APIC response

Questions?

For more information, contact your sales representative or Customer Support at 800.323.9088.