BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)1505

FDA device recall Z-0801-2020 · posted 2020-01-13 · Terminated

Recall details

Recalling firm

Flexicare Medical Ltd.

Reason for recall

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.

Action taken

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 provided - If you have experienced any adverse events associated with the recalled products. - Check your stock and quarantined inventory - Send completed response forms marked for the attention of Product Manager Anesthesia to email Ian.ross@flexicare.com or by fax to 949-450-9992 - Identify and notify your customers that were shipped product from the affected lot numbers If you have any questions, please call Product Manager Anesthesia, at 949-450-9999 ext. 102 or email at Ian.Ross@flexicare.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CCW

Quantity affected

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

Date initiated

2019-11-27

Date posted

2020-01-13

Date terminated

2021-04-27

Location

Taff, United Kingdom