Karl Storz Endoscopy Recall: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01
Karl Storz Endoscopy Recall: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Karl Storz Endoscopy; Product: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units); Reason for recall:
| Recalling firm | Karl Storz Endoscopy |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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 |
| Recall initiated | 20210910 |
| Recall number | Z-0184-2022 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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