Z-1931-2026Class II

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

Name: Z-1931-2026 LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Creator: LSL Healthcare Inc.
Published: 2026-03-09
License: https://open.fda.gov/license/

LSL Healthcare / initiated 2026-03-09 / Open, Classified / root cause: sterility

FDA source

LSL Healthcare Inc. began a recall of LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H on 2026-03-09. FDA classified it as Class II and gives the reason as "Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1931-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-09
Posted: 2026-04-22
Recalling firm: LSL Healthcare
Product: LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Product code: OXQ Dressing Change Tray
Reason for recall: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: LSL 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, [email protected].
Quantity in commerce: 220 units
Distribution: US Nationwide distribution in the states of MD, IL, MN.
Product codes and lots: Lot Code: Model No. 2925H; UDI-DI 00661392052635; Lot#6B3022, Expiration Date 11/30/2026 GTIN: (01)00661392052635(10)6B3022(17)261130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1931-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1929-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1930-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1931-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1932-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1933-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code OXQ

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)