Recall Z-0801-2020 ยท CCW Laryngoscope, Rigid
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
| Date | Jan 13, 2020 (initiated Nov 27, 2019) |
| Status | Terminated |
| Reason | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/27/2019, the firm "Flexicare" sent a "Urgent: medical Device Recall" letter via USPS Priority mail. The letter informed consignees of the recall. In addition to informing consignees of the recall the letter asked consignees to take the following actions: Complete the acknowledgment and receipt form and return this form to Flexicare Inc. On receipt of the form you will be contacted by a representative of Flexicare Inc. to make all necessary further arrangements. The form asked the following of the consignee: -Acknowledge that you have read and understand the recall instructions provide |
| Quantity | 1,024,890 devices |
| Distribution | US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.