FDA Medical Device Recalls (openFDA)
LSL Healthcare Inc.: LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
- Recall number
- Z-1932-2026
- Recalling firm
- LSL Healthcare Inc.
- Product
- LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
- Status
- Open, Classified
- Initiated
- 2026-03-09
- Posted
- 2026-04-22
- Terminated
- not on file
- Reason
- Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- 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, LSLorderinquiries@lslhealcare.com.
- Quantity
- 2200 units
- Distribution
- US Nationwide distribution in the states of MD, IL, MN.
- Lot, serial or model codes
- Lot Code: Model No. 3131; UDI-DI 00661392054271; Lot#6A3139, Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- 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