Recall Z-1471-2020 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
| Date | Mar 31, 2019 |
| Status | Terminated |
| Reason | A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades. |
| Root cause | Error in labeling |
| Action | On 03/31/2019 the firm communicated a "Field Safety Notice Medical Device Recall" letter to customers via FedEx informing them the firm has identified that the disinfection levels outlined in Table 9 (Table 9. System Risk Classification) on page 23 of the Operations & Maintenance Manual (OMM) incorrectly indicates (X in the table cell) that low level disinfection is the minimum disinfection level required for the reusable Titanium video laryngoscope. The correct reference should be an X in the table cell indicating that high-level disinfection is required. The error in Table 9 contradicts the |
| Quantity | 239 manuals |
| Distribution | US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.