Device recall
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
- Recall number
- Z-3126-2026
- 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
- MCY
- Device type
- Wound Dressing Kit
- 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
- 1100 kits
- Code info
- 1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States