Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.
1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881; 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827; 3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730; 4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629; 5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086; 6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081; 7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351; 8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085; 9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →