Medline Cardiac Catheterization Kits Recalled for Particulate Contamination
Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall. Per the rubric, FDA Class I recalls are never scored below 4. Although no reported illnesses or injuries are mentioned in the source, particulate contamination in the fluid path of cardiac devices used during invasive procedures presents significant risk of harm.
Plain-English summary
Medline Industries, LP is recalling multiple cardiac catheterization and angiography kits due to the identification of particulate contamination within the fluid path of the manifolds. The recalled products include various manifold and kit configurations used in cardiac procedures.
The affected kits were distributed in the United States and internationally to countries including Australia, Canada, Japan, South Korea, Netherlands, and Singapore. A total of 322,460 kits with multiple Medline Kit Numbers/SKUs are included in this recall, with specific lot numbers identified for each SKU.
This is a Class I recall issued by the FDA. Patients and healthcare facilities that have received these products should discontinue use immediately. Healthcare providers should contact Medline Industries, LP for instructions regarding the return or replacement of affected kits. Any adverse events or complications potentially related to the use of these kits should be reported to the FDA.
The recalled product
- Product
- 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/S
- Manufacturer
- Medline Industries, LP
- Hazard
- particulate-contamination
- device-defect
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 Number/SKU 60010195: UDI/DI each 10193489040234
- UDI/DI case 40193489040235
- Lot Number: 24CBF820
- Lot Number: 24DBR149
- Lot Number: 24HBO437
- Lot Number: 24IBJ827
- Lot Number: 25ABI082
- Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436
- UDI/DI case 40193489042437
- Lot Number: 25BBI613
- Lot Number: 25BBR862
- Lot Number: 25DBC934
- Lot Number: 25DBT579
- Lot Number: 25FBF145
- Lot Number: 25GBJ123
- Lot Number: 25HBQ032
- Lot Number: 25IBF219
- Lot Number: 25JBS750
- Lot Number: 25LBD357
- Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273
Distribution
Distributed nationwide across the United States.