3M Company Health Care Business 3m Center 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.