Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Reported: September 27, 2023 Initiated: July 7, 2023 #Z-2589-2023
Product Description
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Reason for Recall
Flexible intubation endoscopes sterility assurance can not be confirmed.
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- 218 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only. Recalled by Karl Storz Endoscopy. Units affected: 218 units.
Why was this product recalled? ▼
Flexible intubation endoscopes sterility assurance can not be confirmed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2023. Severity: Moderate. Recall number: Z-2589-2023.
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