Recall Z-0184-2022 ยท CAL Laryngoscope, Non-Rigid
Karl Storz Endoscopy
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
| Date | Sep 10, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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-Mai |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.