Recall Z-0184-2022— Karl Storz Endoscopy
Class II · Ongoing
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2021-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units). 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..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-10
- Firm location
- El Segundo, CA, United States
Product description
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.