BD—Bard Magic 3 Intermittent Catheters: ​May Be Labeled with Incorrect Expiration Date

September 2, 2020 | Risk Management News

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ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an August 19, 2020, Medical Device Recall letter submitted by an ECRI member hospital, BD states that the above catheters may be labeled with an incorrect expiration date. BD also states that expiration date on the packaging of the above catheters (see picture A in the letter) is intended to be the shortest expiation of all components in the package; however, the insertion supply kit (see picture B in the letter) expires on 2020-11-29, which is before the expiration date on the above catheter packaging. BD further states that the overall health risk associated with the extended expiration date is low. It is improbable that the cleansing wipe will become dry within the expiration of the product label. Even though it is unlikely to occur, if an expired cleansing pad that becomes dry is unsuccessful in cleaning the skin surface before insertion of the catheter, a patient could experience mucosal irritation and/or an increased risk of a urinary tract infection (UTI). Symptoms related to the skin irritation are expected to be transient in nature and resolve without medical intervention. However, management of a...

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