Device recall
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
- Recall number
- Z-0272-2027
- 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
- 10 kits
- Code info
- UDI/DI 10198459142031 (each) 40198459142032 (case), Lot numbers: CDS840215P
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States