Device recall

Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.

FDA recall source

Recall number

Z-3019-2026

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

OES

Device type

Cardiac Catheterization Kit

Reason

Kits contain a potentially contaminated component which were recalled by the manufacturer

Root cause

Process change control

Quantity

71 kits

Code info

1) Medline Kit SKU DYNJ909393A, UDI/DI 10195327613945 (each) 40195327613946 (case) Lot Number 25ILA297; 2) Medline Kit SKU DYNJ910295D, UDI/DI 10198459586477 (each) 40198459586478 (case), Lot Number 26CBT178.

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