Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 3M" Tube Securement Device, Small

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall 3M" Tube Securement Device, Small see related information
Date Initiated by Firm February 20, 2024
Date Posted April 03, 2024
Recall Status1 Open3, Classified
Recall Number Z-1475-2024
Recall Event ID 94039
Product Classification Tape and bandage, adhesive - Product Code KGX
Product 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
Code Information REF 1500U, SKU 70-2011-8908-4, UDI-DI 30707387792405, Lot numbers: 33TNNN: Exp. 2025-11-09; 33TNMH: Exp. 2025-11-08; 33KNWC: Exp. 2024-06-02; 33KNJD: Exp. 2024-06-01; 33KND8: Exp. 2024-05-31. REF 1501U, SKU 70-2011-8924-1, UDI-DI 30707387792399, Lot numbers: 33TNH3: Exp. 2025-11-08; 33TNDC: Exp. 2025-11-07; 33KTDY: Exp. 2024-06-11; 33KWM3: Exp. 2024-06-15; 33KTWT: Exp. 2024-06-13; 33KWHE: Exp. 2024-06-14; 33KTLA: Exp. 2024-06-12; 33KTFP: Exp. 2024-06-11; 33KT9M: Exp. 2024-06-10; 33KP6M: Exp. 2024-06-03.
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5w-06
Saint Paul MN 55144-0001
Manufacturer Reason
for Recall		 Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.
FDA Determined
Cause 2		 Process control
Action The recalling firm issued letters addressed to either the distributor, health care customer, or retailer dated 2/14/2024 via email or certified mail on 2/20/2024. The distributor letter explained the issue and provided the affected lot numbers with photographs embedded in the letter to illustrate where to find the model numbers and lot numbers that were affected. The distributors were to immediately discontinue distribution of the affected products and quarantine them for destruction. They were to complete the Distributor Acknowledgement Form to acknowledge they have read and understand the letter, to report if they have affected product in stock and have destroyed them per facility policy, and to email the completed form back to the recalling firm. The distributor is to notify any of their customers who have purchased the affected products using the enclosed Customer Letter dated 2/14/2024 and the Customer Acknowledgement Form. The customer letter enclosed with the distributor letter was similar to the distributor letter except it instructed them to contact the distributor for the next steps on requesting credit for the affected products before destruction and to complete the Customer Acknowledgement Form. The letter for the health care customer was similar to the distributor letter but it did not contain instructions to notify customers who were distributed the affected product. It did request the health care customer to ensure the notice was passed to all who need to be aware within their organization or to any department where the affected product has been transferred.
Quantity in Commerce 265,435 eaches
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MN, NC, NH, NY, OH, PA, TX, VA, and WA, including PR. The countries of Australia, Austria, Canada, China, Finland, Germany, Ireland, New Zealand, Norway, Poland, Sweden, and the United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-