Recall Z-0575-2024
Karl Storz Endoscopy · initiated October 24, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
Codes / lots: REF/UDI-DI: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285 All lot numbers.
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: 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
Details
- Recall number
- Z-0575-2024
- Initiated
- October 24, 2023
- Posted by FDA
- December 18, 2023
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 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
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0571-2024 Class II | Injection Needle, REF: 25207The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | 10/24/2023Open, Classified |
| Z-0572-2024 Class II | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182AThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | 10/24/2023Open, Classified |
| Z-0573-2024 Class II | Injection Needle, LUER-lock,0.8mm, REF: 26175PDThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | 10/24/2023Open, Classified |
| Z-0574-2024 Class II | Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80…The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | 10/24/2023Open, Classified |