Recall Z-1473-2024 ยท HET Laparoscope, Gynecologic (And Accessories)
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
| Date | Apr 3, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | Inadequate reprocessing validation evidence |
| Root cause | Under Investigation by firm |
| Action | On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the products listed above (Table 1) 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 KARL STORZ a list of customers who received/may have received the products liste |
| Quantity | 27 units |
| Distribution | US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951343 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES KARL STORZ Endoscopy-America, Inc., Apr 11, 1996 |