Recalls / —

—#184622

Product

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

FDA product code

OGR — Ear, Nose, And Throat Surgical Tray

Device class

Class 1

Medical specialty

Ear, Nose, Throat

Affected lot / code info

Lot 20GBF988 (Expiration 06/30/2024); 20HBM404 (Expiration 06/30/2024); 20JBG876 (Expiration 09/30/2024)

Why it was recalled

The cylindrical sponge component is not x-ray detectable.

Root cause (FDA determination)

Process control

Action the firm took

Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.

Recalling firm

Firm

Medline Industries Inc

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

Foreign distribution only - Canada.

Timeline

Recall initiated

2020-11-13

Terminated

2021-10-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.