Device recall
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.
- Recall number
- Z-0175-2027
- Event id
- 99886
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Sep 2, 2026
- Center classification date
- Oct 15, 2026
- Product code
- KDD
- Device type
- Kit, Surgical Instrument, Disposable
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 235 kits
- Code info
- 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.
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States