[pending] Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) P
Pending LLM rewrite. Source: FDA_DEVICE Z-1334-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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 DRESS
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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