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Karl Storz Endoscopy Recall: Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Ins

Karl Storz Endoscopy Recall: Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Ins is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Karl Storz Endoscopy; Product: Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended

Recalling firmKarl Storz Endoscopy
ProductFlexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Reason for recallUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide distribution - U.S. Nationwide distribution including in the states of CA, NY, PA, AZ, OH, NJ, FL, NC, IL, SC, MA, IA, ND, WI, UT, AR, GA, WA, KY, CO, TX, TN, AL, LA, NE, WV, MO, MN, VA, MT, CT, MI, IN, NM, NV, ME, VT, NH, WY, DC, DE, OR, OK, MD, ID, AK, MS, KS, HI, RI, SD and the country
Recall initiated20200727
Recall numberZ-2895-2020
Categorydevice
StateCA
CountryUnited States

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