Medline Cardiac Catheterization Kits Recalled for Particulate Contamination
Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.
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: This is an FDA Class I recall of medical devices used in invasive cardiac procedures. Class I recalls are classified as severe by the rubric; the presence of particulate contamination in fluid pathways during cardiac interventions creates a direct risk of harm to patients undergoing critical procedures.
Plain-English summary
Medline Industries, LP is recalling 567,675 cardiac catheterization kits and related accessories due to the presence of particulate matter within the fluid path of the manifolds. The affected products include various configurations such as 3 Valve Man Kits, Heart Cath Packs, Angio Drape Cardiac Packs, TAVR Packs, and other related kits, distributed nationwide in the US and internationally to Austria, Australia, Canada, Japan, South Korea, Netherlands, Singapore, and Slovakia.
The particulate contamination poses a potential risk during cardiac catheterization procedures. Hospitals, catheterization laboratories, and other healthcare facilities that have received these kits should discontinue use immediately and contact Medline Industries for guidance on returned or replacement products.
Consumers and healthcare providers with questions about this recall should contact Medline Industries directly.
The recalled product
- Product
- 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medli
- 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 30193489040238
- Lot Number: 91637
- Lot Number: 91667
- Lot Number: 92995
- Lot Number: 95615
- Lot Number: 97091
- Lot Number: 102177
- Lot Number: 104282
- Lot Number: 108922
- Lot Number: 110250
- Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319
- UDI/DI case 30193489040313
- Lot Number: 89290
- Lot Number: 91926
- Lot Number: 98742
- Lot Number: 100867
- Lot Number: 103336
- Lot Number: 112524
- Lot Number: 120251
Distribution
Distributed nationwide across the United States.