Recall Z-0571-2024 ยท GCF Proctoscope
Karl Storz Endoscopy
Injection Needle, REF: 25207
| Date | Dec 18, 2023 (initiated Oct 24, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 arr |
| Quantity | 1 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945209 | PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS KARL STORZ Endoscopy-America, Inc., Mar 6, 1995 |