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

FDA device recall Z-0112-2018 · posted 2017-11-18 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

Products labeled as sterile were distributed prior to sterilization

Action taken

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."

Root cause

Employee error

Status

Terminated

Product code

BSY

Quantity affected

190 units

Distribution

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

Date initiated

2017-10-10

Date posted

2017-11-18

Date terminated

2020-08-04

Location

Northfield, IL