LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

FDA device recall Z-1809-2024 · posted 2024-05-13 · Open, Classified

Recall details

Recalling firm

Karl Storz Endoscopy

Reason for recall

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

GEX

Quantity affected

85

Distribution

Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.

Date initiated

2024-04-01

Date posted

2024-05-13

Location

El Segundo, CA

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