Recall Z-2447-2019 ยท EOQ Bronchoscope (Flexible Or Rigid)
Karl Storz Endoscopy
Flexible Intubation Fiberscope, Model # 11301AB1
| Date | Apr 24, 2019 |
| Status | Terminated |
| Reason | The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer. |
| Root cause | Process control |
| Action | The firm mailed a "safety alert" on April 24, 2019 via FedEx. 2nd day delivery. The safety alert advised customers to do the following: 1. If you use the following automated processes, the high level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed: Reprocessing Method Impact, Medivators AER * Patient Safety may be Compromised, STERIS System 1E (SS1E)** Patient Safety may be Compromised The above connectors can only connect onto one port, therefore leaving the other port open. Depending on the reprocessing system, the cycle could result in an error |
| Quantity | 14 scopes |
| Distribution | US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.