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U.S. Department of Health and Human Services

Class 2 Device Recall LSL Healthcare

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 Class 2 Device Recall LSL Healthcaresee related information
Date Initiated by FirmDecember 22, 2025
Date PostedJanuary 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1219-2026
Recall Event ID 98245
Product Classification Peripheral catheter insertion kit - Product Code OWL
ProductLSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Code Information Lot Code: Model No. 2519CP; UDI-DI 00661392048157; Lot# 5G3119; Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731
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
Manufacturer Reason
for Recall		BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
FDA Determined
Cause 2		Under Investigation by firm
ActionLSL issued issued an URGENT: Kit Component Recall notice to its sole consignee on 12/22/2025 via email. The notice explained the issue and requested the following actions: "1. Immediately stop using the affected kits in your facility. 2. Inspect all inventory locations within your facility and destroy all affected kits according to your facility's disposal process. If destruction is not feasible immediately, 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 below. 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. Provide a copy of the attached customer letter to all of these customers to inform them of the recall on behalf of BD & LSL. 4. Complete the attached Response Form and return it to the LSL contact provided on the form if you have any of the affected products in stock. This will help LSL acknowledge your receipt of this notification. Please indicate the quantity of affected products identified in your facility and confirm whether this inventory was destroyed or returned. 5. If you require assistance with this process, please contact your LSL representative or reach out to LSL using the contact information provided below. LSL Industries LLS, dba LSL Healthcare 6200 W. Howard Street Nile, IL, 60714 (888) 225-5575 | lslorderinquiries@lslhealthcare.com" LSL will provide credit for any destroyed products from the specific lot numbers mentioned above to customers who purchased the affected items directly from LSL. This will occur upon receipt of the completed Response Form.
Quantity in Commerce1400 kits
DistributionUS Nationwide distribution in the state of Idaho.
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.
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