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Karl Storz Endoscopy Recall 92796

Description: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Karl Storz Endoscopy Recall 92796 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2589-2023
Event ID92796
Event DescriptionFive S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Product TypeDevices
DistributionWorldwide - 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.
Quantity218 units
Recall ReasonFlexible intubation endoscopes sterility assurance can not be confirmed.
Device Classification20230927
Device Code InfoUDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
Center Classification Date20230915
Recall Initiation Date20230707
Recalling FirmKarl Storz Endoscopy
Initial Notification Letter
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