Recall Z-1475-2024— 3M Company - Health Care Business
Class II · Ongoing
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2024-02-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-20
- Firm location
- Saint Paul, MN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.