Recall Z-1809-2024 ยท GEX Powered Laser Surgical Instrument
Karl Storz Endoscopy
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
| Date | May 13, 2024 (initiated Apr 1, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 re |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942786 | KARL STORZ LASER ACCESSORIES KARL STORZ Endoscopy-America, Inc., Sep 16, 1994 |