Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
FDA device recall Z-0572-2024 · posted 2023-12-18 · Open, Classified
Recall details
- Recalling firm
- Karl Storz Endoscopy
- 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.
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FBK
- Quantity affected
- 990
- 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
- Date initiated
- 2023-10-24
- Date posted
- 2023-12-18
- Location
- El Segundo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS (K950976) | KARL STORZ Endoscopy-America, Inc. | 1995-03-21 |