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Parker Quality & Compliance

PQC Reg Watch

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Device recall

MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108

FDA recall source

Recall number
Z-0271-2027
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
2569 units
Code info
UDI/DI 10888277668843 (each) 20888277668840 (case), Lot numbers: 45025120094, 45025120253
Distribution
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Voluntary or mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States