LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Summary
The FDA issued a Class II for LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 by LSL Healthcare Inc.. Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility..
Details
Source
Device Recall
External ID
Z-1930-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Lot/Code Info: Lot Code: Model No. 1555; UDI-DI 00661392002326; Lot# 260221, Expiration Date 02/28/2027 GTIN: (01)00661392002326(10)260221(17)270228
Quantity Affected: 100 units
Reason for Recall
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Distribution
US Nationwide distribution in the states of MD, IL, MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-09
Company
Niles, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LSL Healthcare Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LSL Healthcare Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LSL Healthcare Inc. have FDA actions?
LSL Healthcare Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1930-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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