FDA Enforcement
Class II
Ongoing
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Recall: Z-1930-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1930-2026
- Event ID
- 98631
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- LSL Healthcare Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 29, 2026
- Initiation Date
- March 9, 2026
- Classification Date
- April 22, 2026
- Address
- 6200 W Howard St, N/A, Niles, IL, 60714-3404, United States
Description
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Reason
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Code Info
Lot Code: Model No. 1555; UDI-DI 00661392002326; Lot# 260221, Expiration Date 02/28/2027 GTIN: (01)00661392002326(10)260221(17)270228
Distribution
US Nationwide distribution in the states of MD, IL, MN.
Quantity
100 units