Recall Z-2895-2020 ยท CAL Laryngoscope, Non-Rigid
Karl Storz Endoscopy
Flexible 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.
| Date | Jul 27, 2020 |
| Status | Open, Classified |
| Reason | Updated 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. |
| Root cause | Device Design |
| Action | On 07/27/2020, Urgent Medical Device Correction notices were mailed to customers. Customers were informed that this labeling change corrects the instructions for sterilization of the impacted endoscopes using STERRAD or EtO modalities. Do not use any impacted endoscope until you have confirmed that it has been appropriately sterilized in accordance with the instructions in the correction notice or via another method specified in instructions for use with updated sterilization information. When sterilizing one of the impacted flexible intubation endoscopes with the STERRAD NX Advanced Cycle or |
| Quantity | 428 |
| Distribution | Worldwide 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.