Medline Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.
What this means for you
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 medical devices used for invasive procedures (blood collection/culture) with a risk-of-harm hazard (non-sterile contamination with bacteria). No reported illnesses or injuries are stated in the source, so the score is 3 per the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits containing Cardinal Health Webcol Large Alcohol Prep Pads. The affected kits include Blood Culture Kit SKU DYNDH1520 and Blood Draw Kit SKU EBSI1317, distributed nationwide. Cardinal Health determined the Webcol Large Alcohol Prep Pads to be non-sterile following discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit.
The recall affects specific lot numbers for each kit type. Blood Culture Kit SKU DYNDH1520 lots 2025101301 and 2025113001 are affected. Blood Draw Kit SKU EBSI1317 lots 2025120390 and 2026022390 are affected. A total of 4050 kits have been recalled.
Consumers and healthcare facilities should stop using these kits and contact Medline Industries for instructions on returns or replacements. The non-sterile condition creates a potential risk of infection when these kits are used for blood collection or culture procedures.
The recalled product
- Product
- Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
- Manufacturer
- Medline Industries, LP
- Hazard
- bacterial-contamination
- non-sterile
- infection-risk
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 (8)
- Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679
- UDI/DI case 20193489197676
- Lot Number : 2025101301
- Lot Number : 2025113001
- Medline Kit SKU EBSI1317: UDI/DI each 10193489195804
- UDI/DI case 20193489195801
- Lot Number : 2025120390
- Lot Number : 2026022390.
Distribution
Distributed nationwide across the United States.
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