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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER

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  Class 2 Device Recall MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER see related information
Date Initiated by Firm October 10, 2017
Date Posted November 18, 2017
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-0112-2018
Recall Event ID 78319
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Code Information Lot 2861707008
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Brad Schmidt
866-359-1704
Manufacturer Reason
for Recall		 Products labeled as sterile were distributed prior to sterilization
FDA Determined
Cause 2		 Employee error
Action 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."
Quantity in Commerce 190 units
Distribution FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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