Recall Z-1055-2022 · EOQ Bronchoscope (Flexible Or Rigid)
Karl Storz Endoscopy
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
| Date | Apr 1, 2022 |
| Status | Open, Classified |
| Reason | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| Root cause | Under Investigation by firm |
| Action | On 04/01 and 6/2022, the firm emailed an "Urgent Medical Device Recall" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing. Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed. Testing showed that the required efficacy level of disinfection using CIDEX OPA was no |
| Quantity | All Serial Numbers manufactured/distributed since January 2018 |
| Distribution | U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) Karl Storz Endoscopy America, Dec 29, 2021 |