Device recall

Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F

FDA recall source

Recall number

Z-3123-2026

Event id

99669

Status

Ongoing

FDA classification

Class I

Recalling firm

Medline Industries, LP

Report date

Sep 23, 2026

Posted

Sep 14, 2026

Initiated

Aug 11, 2026

Center classification date

Sep 14, 2026

Product code

OFF

Device type

Central Venous Catheter Tray

Reason

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Root cause

Nonconforming Material/Component

Quantity

447 kits

Code info

1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States