| Class 2 Device Recall Injection Needle, curved, straight, 23 cm, Injection Needle distal 45degrees |  |
Date Initiated by Firm | October 24, 2023 |
Date Posted | December 18, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0575-2024 |
Recall Event ID |
93328 |
Product Classification |
Laryngoscope, rigid - Product Code CCW
|
Product | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D |
Code Information |
REF/UDI-DI: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285
All lot numbers. |
Recalling Firm/ Manufacturer |
Karl Storz Endoscopy 2151 E Grand Ave El Segundo CA 90245-5017
|
For Additional Information Contact | Kathy Strange 774-284-1736 |
Manufacturer Reason for Recall | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. |
FDA Determined Cause 2 | Device Design |
Action | On 10/24/23, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following:
1) Discontinue use of all affected Injection Needles.
2) Pass on the Recall Notice to all users of the affected products and all other persons who need to be aware within your organization.
3) If you have or may have distributed the products listed, please identify and
promptly notify those recipients, or provide the recalling firm with a list of customers
who received/may have received the products listed.
4) Contact Customer Support to arrange for the return of affected devices by calling 800-421-0837.
5) Return the completed Customer Reply Form via email to karlstorz5190@sedgwick.com
For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com |
Quantity in Commerce | 4,878 |
Distribution | US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI
OUS: Mexica, Canada, Germany |
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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