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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M

FDA recall source

Recall number
Z-3023-2026
Event id
99507
Status
Ongoing
FDA classification
Class II
Recalling firm
Medline Industries, LP
Report date
Sep 2, 2026
Posted
Aug 26, 2026
Initiated
Jul 10, 2026
Center classification date
Aug 26, 2026
Product code
FTN
Device type
Plastic Surgery And Accessories Kit
Reason
Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause
Process change control
Quantity
15 kits
Code info
UDI/DI 10198459447327 (each) 40198459447328 (case), kit lot number 25JBE079.
Distribution
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Voluntary or mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States