Device recall
MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUDYNJ908124B.
- Recall number
- Z-0274-2027
- Event id
- 99960
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Sep 9, 2026
- Center classification date
- Oct 22, 2026
- Product code
- PUI
- Device type
- Drape, Surgical, Exempt
- Reason
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Root cause
- Under Investigation by firm
- Quantity
- 233 kits
- Code info
- Medline Product Number/SKU DYNJP6101, UDI/DI 10198459447594 (each) 40198459447595 (case), Lot Number 26GBC179, Medline Product Number/SKU DYNJP6101, UDI/DI 10198459217623 (each) 40198459217624 (case), Lot Number 26HBV769, Medline Product Number/SKU DYNJP6101, UDI/DI 10198459217623 (each) 40198459217624 (case), Lot Number 26GBJ833, Medline Product Number/SKU DYNJP6101, UDI/DI 10198459217623 (each) 40198459217624 (case), Lot Number 26EBT593, Medline Product Number/SKU DYNJP6106, UDI/DI 10198459012648 (each) 40198459012649 (case), Lot Number 26DLB020, Medline Product Number/SKU DYNJP6108, UDI/DI 10198459012648 (each) 40198459012649 (case), Lot Number 26DLA431, Medline Product Number/SKU DYNJP6108, UDI/DI 10198459012648 (each) 40198459012649 (case), Lot Number 26BLA251.
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States