Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LSL Healthcare IV Start Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LSL Healthcare IV Start Kitsee related information
Date Initiated by FirmMarch 09, 2026
Date PostedApril 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1932-2026
Recall Event ID 98631
Product Classification I.V. start kit - Product Code LRS
ProductLSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Code Information Lot Code: Model No. 3131; UDI-DI 00661392054271; Lot#6A3139, Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121
FEI Number 1420054
Recalling Firm/
Manufacturer		 LSL Healthcare Inc.
6200 W Howard St
Niles IL 60714-3404
For Additional Information ContactDemetrius Bridges
773-878-1100 Ext. 1120
Manufacturer Reason
for Recall		Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
FDA Determined
Cause 2		Under Investigation by firm
ActionLSL Healthcare issued an UREGNT: Kit Component Recall to its consignees on 3/9/2026 via email. The notice explained the issue and requested the following: "1. Immediately stop using the affected kits in your facility. 2. Inspection all inventory locations within your facility and destroy all affected kits according to your facility's disposal process. If immediate destruction is not feasible, the products should be quarantined until proper disposal can occur. If disposal is not possible, please request a Return Merchandise Authorization (RMA) to return these kits as indicated.. 3. This recall should be executed at the distributor, hospital, and user levels. Identify all customers within your distribution network who may have purchased the affected products listed in this notification. 4. Complete the attached Response Form and return to the LSL contact provided on the form if you have any of the affected product in stock." For assistance with this process, please contact your LSL representative or LSL at LSL Healthcare, 6200 W. Howard Street, Nile, IL 60714, (888)225-5575, LSLorderinquiries@lslhealcare.com.
Quantity in Commerce2200 units
DistributionUS Nationwide distribution in the states of MD, IL, MN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-