TemporaryFDAOngoing
Can cause harm that is usually temporary.
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
Check the device or its packaging for
Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 26BBA206; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25LBQ023; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25KBR149; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25EBF588; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25ABI296; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 24IBP190; Medline Product Number/SKU DYNJ0538615J; UDI/DI 10195327673376 (each) 40195327673377 (case), Lot number 24DBC864.
- Why
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- Distributed
- US Nationwide distribution.
- Company
- Medline Industries, LP
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0175-2027 · retrieved 15 October 2026
Read the official notice