Medline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.
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 (alcohol prep pads) used in IV procedures on patients including neonates. Non-sterile materials pose a significant risk of infection and harm, though the source text does not report any illnesses or injuries to date.
Plain-English summary
Medline Industries, LP is recalling specific lots of medical convenience kits that contain Cardinal Health Webcol Large Alcohol Prep Pads. The kits affected include NEONATAL IV START KIT, IV SECUREMENT KIT, IV START KIT, NEONATAL IV SECUREMENT KIT W/SHIELD, IV START & SECUREMENT KIT, and IV START KIT WITHOUT TUBING under the Medline and Centurion brand names. A total of 28,550 kits have been distributed nationwide.
Cardinal Health determined that the Webcol Large Alcohol Prep Pads are non-sterile following the discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit. The contamination was identified during quality control testing.
Specific lot numbers and product identifiers (UDI/DI codes) are listed by kit type in the FDA recall notice. Consumers and healthcare facilities that have received these kits should stop using the affected products. Those seeking information about the specific lots affected should consult the FDA recall notice Z-2043-2026 or contact Medline Industries directly.
The recalled product
- 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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 28,550
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 IV8310E: UDI/DI each 10653160293798
- UDI/DI case 00653160293791
- Lot Number: 2025102390
- Medline Kit SKU IVS1700: UDI/DI each 10653160259213
- UDI/DI case 00653160259216
- 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
- Lot Number: 2025122690
- Lot Number: 2026010590
- Lot Number: 2026010990
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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