Recall Z-1488-2012 ยท EQN Laryngoscope, Nasopharyngoscope
Bomimed Inc
BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
| Date | May 3, 2012 (initiated Dec 8, 2010) |
| Status | Terminated |
| Reason | On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles - all sizes), Model #OL-32D0 to OL-32D4 & OL-32E00, OL-32E0, OL-32E1, OL-32E2, OL-32E3, OL-32E4. |
| Root cause | Process design |
| Action | BOMImed sent a "Medical Device Safety Alert & Correction Action" letter by Fax and Mail on 11/25/2010 to the consignee. The product issue was described and recommended actions to mitigate risk were provided. Contact number is 1-800-667-6276 ext. 234. |
| Quantity | 30 units |
| Distribution | US Distribution to the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.