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U.S. Department of Health and Human Services

Class 2 Device Recall KARL STORZ

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  Class 2 Device Recall KARL STORZ see related information
Date Initiated by Firm July 27, 2020
Create Date August 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-2891-2020
Recall Event ID 86009
Product Classification Laryngoscope, non-rigid - Product Code CAL
Product Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - 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.
Code Information Instruction Manual Version: 01/2020
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact
424-218-8201
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 STERRAD 100NX Flex Cycle, one of the sterilization trays or containers specified below should be used: Model/Use Tray or Container: 11301AA1, 11301BND1/ASP Aptimax Tray (13837); 11301BNX, 11302BDX, 11303BNX/ASP Aptimax Tray (13837), or KARL STORZ SteriTite Container (KSZ-39406AS); 11301BN1, 11302BD2, 11302BDD2/ ASP Aptimax Tray (13837), or KARL STORZ SteriTite Container (KSZ-39402AS) The recommendation for ethylene oxide sterilization is being removed from the labeling of affected endoscopes. Customers are asked to do the following: -Examine your inventory. -Complete, sign, and return the Acknowledgement Response Form. -If impacted endoscopes are in inventory, ensure all relevant personnel in your organization are made aware of the information in this notice. -If you previously purchased a KARL STORZ plastic (Udel) sterilization trays are being used to sterilize impacted endoscopes, you may be entitled to a refund or credit. To inquire about refund/credit or for ordering assistance for SteriTite container for STERRAD sterilization, call Customer Support: 800-421-0837, press 1. -Instruction manuals are being updated for the impacted endoscopes. -Updated documents can be accessed electronically on or after August 7th at https://spwebspace.karlstorz.com/sites/ISRU. Correction Inquiries: Contact Medical Affairs Department at 800-649-8852 or medicalaffairs@karlsto
Quantity in Commerce 2083
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 of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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