| | Class 2 Device Recall Centurion Medline |  |
| Date Initiated by Firm | March 16, 2026 |
|---|
| Date Posted | April 30, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2043-2026 |
|---|
| Recall Event ID |
98692 |
| Product Classification |
I.V. start kit - Product Code LRS
|
| Product | Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E;
2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700;
3. IV START KIT (Centurion), Medline Kit SKU IV8675;
4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12;
5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940;
6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775;
7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12;
8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700;
9. IV START KIT, Medline Kit SKU IV8675;
10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E;
11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940;
12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775. |
|---|
| Code Information |
Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390;
Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2025102390;
Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2025110790;
Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025111890;
Medline Kit SKU IV6940: UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2025112690;
Medline Kit SKU IV8775: UDI/DI each 10888277732537, UDI/DI case 20888277732534, Lot Number: 2025120190;
Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025122690;
Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2026010590;
Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2026010990;
Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2026011990;
Medline Kit SKU IV6940: UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2026012990. |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/16/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the affected product be quarantined pending additional labeling. Consignees were directed to respond to the notice via Website link: https://recalls.medline.com, and upon receipt of the submitted response form, the account will receive over-labels to place on affected inventory, with instructions for the user to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight.
Distributors or those who have further distributed the product are directed to notify those receiving the affected kits, and to include the customers quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to the customers to affix to their affected product.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
|---|
| Quantity in Commerce | 28550 kits |
|---|
| Distribution | US Nationwide distribution. |
|---|
| 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.
|
|
|
|
