Class 2 Device Recall Karl Storz FIVE S Flexible Intubation Videoscope

• Date Initiated by Firm: September 10, 2021
• Create Date: October 29, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0184-2022
• Recall Event ID: 88694
• Product Classification: Laryngoscope, non-rigid - Product Code CAL
• Product: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
• Code Information: All LOTs with remaining shelf life
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: 424-218-8201
• Manufacturer Reason for Recall: During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
• FDA Determined Cause: Under Investigation by firm
• Action: On 09/10/21 recall notices were mailed to customers. Action to be taken by the user 1. Immediately quarantine and discontinue use of the affected products. 2. Pass on this Urgent Field Safety Notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the affected products to third parties, please promptly forward this letter to the recipients of the products and indicate contact details of the recipient on the Acknowledgement and Response Form. 4. Return the Acknowledgment and Response Form by Fax or E-Mail to the contact listed below within 10 calendar days of receipt of this notice. 5. Get in touch with your KARL STORZ representative to return affected products and to discuss suitable alternative products. This notice must be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Complete and return the Customer Acknowledgement and Response Form.
• Quantity in Commerce: 532
• Distribution: US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.