FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Recall
- Recall Number
- Z-0184-2022
- Event Number
- 88694
- Firm
- Karl Storz Endoscopy
- FEI Number
- 3007475226
- Product Code
- CAL
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 10, 2021
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017
Description
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
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.
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.
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
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