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Karl Storz Endoscopy Recall 89881

Description: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Karl Storz Endoscopy Recall 89881 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1055-2022
Event ID89881
Event Description11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
QuantityAll Serial Numbers manufactured/distributed since January 2018
Recall ReasonFailure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Device Classification20220518
Device Code Info11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
Center Classification Date20220510
Recall Initiation Date20220401
Recalling FirmKarl Storz Endoscopy
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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