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Class 2 Device Recall KARL STORZ |
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Date Initiated by Firm |
July 27, 2020 |
Create Date |
August 27, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2890-2020 |
Recall Event ID |
86009 |
Product Classification |
Laryngoscope, non-rigid - Product Code CAL
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Product |
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - 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: 08/2018 |
Recalling Firm/ Manufacturer |
Karl Storz Endoscopy 2151 E Grand Ave El Segundo CA 90245-5017
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For Additional Information Contact |
424-218-8201
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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.
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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 |
91 |
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
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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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