[pending] 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit
Pending LLM rewrite. Source: FDA_DEVICE Z-1330-2026.
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
- 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
- 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 DT22010B
- UDI/DI 10653160351092
- Lot number 25EBC888
- 2) Kit SKU DT22790C
- UDI/DI 10653160996965
- Lot number 25EBO566
- 3) Kit SKU DT22790C
- Lot number 25EBD964
- 4) Kit SKU DYNDA2966A
- UDI/DI 10198459005848
- Lot number 25EBN178
- 5) Kit SKU DYNDA2966A
- Lot number 25EBL624
- 6) Kit SKU DYNDC2208C
- UDI/DI 10889942815333
- Lot number 25EBC706
- 7) Kit SKU DYNDC3107
- UDI/DI 10193489917628
- Lot number 25EBN742
- 8) Kit SKU DYNDH1029C
Distribution
Distributed nationwide across the United States.
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