FDA Medical Device Recalls (openFDA)
LSL Healthcare Inc.: LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
- Recall number
- Z-1219-2026
- Recalling firm
- LSL Healthcare Inc.
- Product
- LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
- Status
- Open, Classified
- Initiated
- 2025-12-22
- Posted
- 2026-01-29
- Terminated
- not on file
- Reason
- BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
- 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 | 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
- 1400 kits
- Distribution
- US Nationwide distribution in the state of Idaho.
- Lot, serial or model codes
- Lot Code: Model No. 2519CP; UDI-DI 00661392048157; Lot# 5G3119; Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWL
- Firm FEI
- 1420054
- Firm city
- Niles
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28