Z-1219-2026Class II

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

Name: Z-1219-2026 LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Creator: LSL Healthcare Inc.
Published: 2025-12-22
License: https://open.fda.gov/license/

LSL Healthcare / initiated 2025-12-22 / Open, Classified / root cause: packaging

FDA source

LSL Healthcare Inc. began a recall of LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit on 2025-12-22. FDA classified it as Class II and gives the reason as "BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1219-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-22
Posted: 2026-01-29
Recalling firm: LSL Healthcare
Product: LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Product code: OWL Peripheral Catheter Insertion Kit
Reason for recall: BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: LSL 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 | [email protected]" 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 commerce: 1400 kits
Distribution: US Nationwide distribution in the state of Idaho.
Product codes and lots: Lot Code: Model No. 2519CP; UDI-DI 00661392048157; Lot# 5G3119; Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29

Product code OWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)