Device product
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Z-1930-2026
Product summary
- Event
- Event 98631
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-1930-2026
Official wording
Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Code information: Lot Code: Model No. 1555; UDI-DI 00661392002326; Lot# 260221, Expiration Date 02/28/2027 GTIN: (01)00661392002326(10)260221(17)270228
Distribution pattern: US Nationwide distribution in the states of MD, IL, MN.
Derived failure modes
-
Unknown
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.