LASER Application Instrument (Karl Storz) – Sterilization Concern (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.

Recommended Action

Per FDA guidance

On 4/1/24, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following: 1) Quarantine and discontinue use of affected devices. 2) Pass on the recall notice to all users of the affected devices and to all other persons who need to be aware within your organization. 3) If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide the recalling firm a list of customers who received/may have received the products listed. 4) Complete and return the customer reply form via email to karlstorz4835@sedgwick.com 5) If you have product to return contact the firm at the following phone numbers: For Human Product Telephone: 800-421-0837 Option 1 For Vet Product Telephone: 800-955-7832 Option 1 The firm has placed all affected product on hold and has ceased the distribution of the affected product in the U.S. until further notice. For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com