Medline medical convenience kits recalled for particulate contamination
Medline Industries is recalling cardiac medical convenience kits containing Namic Manifolds due to the presence of particulate matter within the fluid path. 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: This is an FDA Class I recall as explicitly stated in the agency classification. Per the rubric, Class I recalls are scored no lower than 4. Although no illnesses or injuries are reported in the source text, the presence of particulate contamination in cardiac catheterization and interventional kits poses a potential risk of serious harm.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits that contain Namic Manifolds. The recall affects 17 different kit models with various Medline kit numbers and SKUs, including MTS, DBD-MTS, CARDIAC CATH PACK, CATH LAB TRAY, CATH LAB PACK-LF, CATH LAB ANGIOGRAPHY PACK, CLOT RETRIEVAL PACK, TAVR PACK, and DIAGNOSTIC 2 PACK models.
Medline has identified the presence of particulate within the fluid path of the Manifolds contained in these kits. The recall involves 21,119 kits distributed in the United States and internationally to Austria, Australia, Canada, Japan, South Korea, Netherlands, Singapore, and Slovakia.
The recalled kits span multiple lot numbers across all affected kit models. Customers who have received these kits should contact Medline Industries, LP for further instructions regarding the recalled products.
The recalled product
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY,
- Manufacturer
- Medline Industries, LP
- Affected units
- 21,119
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 60010508: UDI/DI each 10193489040340
- UDI/DI case 40193489040341
- Lot Number: 23KBN009
- Lot Number: 23LBI829
- Lot Number: 24ABH036
- Lot Number: 24BBG055
- Lot Number: 24EBO156
- Lot Number: 24GBS605
- Lot Number: 24IBK765
- Lot Number: 25ABR102
- Lot Number: 25CBK686
- Lot Number: 25DBR341
- Lot Number: 25EBB568
- Lot Number: 25FBB624
- Lot Number: 25GBC747
- Lot Number: 25HBF702
- Lot Number: 25JBJ140
- Lot Number: 26ABB718
- Lot Number: 26BBI625
- Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872
Distribution
Part of a larger recall action
This product is one of 11 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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