LSL Healthcare IV Start Kit Recall 2,200 Units Class II
Summary
LSL Healthcare Inc. initiated a Class II medical device recall for 2,200 units of IV Start Kit, Model/Catalog Number 3131, distributed in MD, IL, and MN. The recall was initiated on March 9, 2026 after kits containing recalled Webcol Large Alcohol Prep Pads (recalled for non-sterility) were distributed. Consignees must immediately stop using affected kits, quarantine or destroy them, and contact LSL Healthcare for Return Merchandise Authorization.
“Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.”
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What changed
LSL Healthcare Inc. issued an urgent recall notice on March 9, 2026, notifying consignees that 2,200 IV Start Kit units (Model 3131, Lot 6A3139) were distributed containing Webcol Large Alcohol Prep Pads that had been recalled for non-sterility. The recall affects products distributed in Maryland, Illinois, and Minnesota. Affected healthcare facilities must immediately cease use of the kits, inspect all inventory locations, quarantine or destroy the products, identify customers in their distribution network who received the affected products, and return a completed Response Form to LSL Healthcare.
What to do next
- Immediately stop using the affected kits in your facility
- Inspect all inventory locations within your facility and destroy all affected kits according to your facility's disposal process
- 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
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall LSL Healthcare IV Start Kit
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall LSL Healthcare IV Start Kit | |
| Date Initiated by Firm | March 09, 2026 |
|---|---|
| Date Posted | April 22, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1932-2026 |
| Recall Event ID | 98631 |
| Product Classification | I.V. start kit - Product Code LRS |
| Product | LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131 |
| Code Information | Lot Code: Model No. 3131; UDI-DI 00661392054271; Lot#6A3139, Expiration Date 01/21/2028 |
| GTIN: (01)00661392054271(10)6A3139(17)280121 | |
| FEI Number | 1420054 |
| Recalling Firm/ | |
| Manufacturer | LSL Healthcare Inc. |
6200 W Howard St
Niles IL 60714-3404 |
| For Additional Information Contact | Demetrius Bridges
773-878-1100 Ext. 1120 |
| Manufacturer Reason
for Recall | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. |
| FDA Determined
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 in Commerce | 2200 units |
| Distribution | US Nationwide distribution in the states of MD, IL, MN. |
| Total Product Life Cycle | TPLC 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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