Recalls / —

—#159165

Product

MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

FDA product code

BSY — Catheters, Suction, Tracheobronchial

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

Lot 2861707008

Why it was recalled

Products labeled as sterile were distributed prior to sterilization

Root cause (FDA determination)

Employee error

Action the firm took

The recall was initiated by mail on 10/10/2017. The letter contained the following directive: "REQUIRED ACTION: 1. Immediately check your stock for item numbers DYNCPE8 (Lot 2861707008) & DYNCSDS12 (Lot 28617070015) place them on hold and complete the attached response form. Quarantine all affected product / lots. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact 866-359-1704."

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern

FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras

Timeline

Recall initiated

2017-10-10

Posted by FDA

2017-11-18

Terminated

2020-08-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #159165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.