Medline medical convenience kits recalled for non-sterile alcohol prep pads
Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving non-sterile medical devices intended for use on high-risk patients (LVAD, central venous catheters, PICC lines). Non-sterile alcohol prep pads used in sterile procedures present a risk of pathogen introduction and infection; although no illnesses have been reported in the source text, the hazard is substantial for vulnerable populations.
Plain-English summary
Medline Industries, LP is recalling 17,550 kits containing Cardinal Health Webcol Large Alcohol Prep Pads. The affected products are multiple medical convenience kit SKUs, including LVAD driveline kits, IV securement sets, CVC dressing change kits, PICC dressing change kits, and other related dressing change and management systems across the Medline and Centurion brands.
Cardinal Health determined that the Webcol Large Alcohol Prep Pads are non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. The recalled kits have been distributed nationwide in the United States.
Consumers should immediately stop using these kits and consult their healthcare provider or contact Medline Industries for guidance on replacement products. The specific lot numbers for each kit SKU are detailed in the recall information and should be checked before use.
The recalled product
- Product
- Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING…
- Manufacturer
- Medline Industries, LP
- Affected units
- 17,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit SKU DT17360: UDI/DI each 10653160264965
- UDI/DI case 00653160264968
- Lot Number: 2025101090
- Medline Kit SKU IVS1975A: UDI/DI each 10653160327936
- UDI/DI case 00653160327939
- Lot Number: 2025100890
- Medline Kit SKU DT5565B: UDI/DI each 00653160126938
- UDI/DI case 10653160126935
- Lot Number: 2025103190
- Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453
- UDI/DI case 20193489195450
- Lot Number: 2025110590
- Lot Number: 2025110790
- Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276
- UDI/DI case 40888277781277
- Lot Number: 2025111990
- Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320
- UDI/DI case 40888277781321
- Lot Number: 2025112490
- Medline Kit SKU DM810: UDI/DI each 10653160304739
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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