Recall Z-1054-2022 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Karl Storz Endoscopy
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
| 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
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope KARL STORZ Endoscopy-America, Inc., Feb 2, 2018 |