Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
- Company
- Karl Storz Endoscopy
- Recall Initiated
- October 24, 2023
- Posted
- December 18, 2023
- Recall Number
- Z-0572-2024
- Quantity
- 990
- Firm Location
- El Segundo, CA
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.
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
Lot / Code Info
REF/UDI-DI: 27030N/4048551257180, 27182A/4048551081457 All lot numbers.
Root Cause
Device Design
Action Taken
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