Recall Z-2425-2019 ยท GWG Endoscope, Neurological
Karl Storz Endoscopy
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
| Date | Feb 20, 2019 |
| Status | Terminated |
| Reason | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. |
| Root cause | Employee error |
| Action | A safety alert was sent to all affected consignees on 7/26/209 via FED Ex. The safety alert informed consignees of the following: 1. From the reprocessing point of view, depending on the methods of reprocessing at your facility, the scope built with the incorrect port may impact the reprocessing outcome. 2. When using STERIS System for sterilization, the above QKC connectors connect onto one port, and leaving the other QKC connector open. The STERIS system, however, will complete the cycle without any indication of a problem, yet the sterility of the scope cannot be guaranteed. If you |
| Quantity | 22 scopes |
| Distribution | US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002788 | KSEA NEURO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc., Oct 23, 2000 |