Medline Medical Convenience Kits with Namic Manifold recalled
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models 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 of a medical device used in critical catheterization procedures where particulate contamination in the fluid path poses significant risk of harm to patients, meeting the Severe threshold for Class I medical device recalls.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits containing Namic Manifolds. The recalled kits are labeled as: (1) ANGIOGRAPHY CATH LAB, Kit Number DYNJ23532C; (2) CATH LAB PACK, Kit Number DYNJ65185; and (3) ANGIO KIT, Kit Number VASC1057.
The recall was initiated because particulate matter has been identified within the fluid path of the Manifolds.
The recalled kits were distributed nationwide in the United States and internationally to Australia, Austria, Canada, Japan, Korea, the Netherlands, Singapore, and Slovakia. A total of 508 kits are affected.
Facilities using these kits should review their stock against the lot numbers and UDI codes provided by Medline. Healthcare providers should contact Medline for instructions regarding return or disposal of affected products.
The recalled product
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
- Manufacturer
- Medline Industries, LP
- Hazard
- particulate-contamination
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 (13)
- Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872
- UDI/DI case 40193489460873
- Lot Number: 25DMA809
- Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146
- UDI/DI case 40193489253147
- Lot Number: 23GBA252
- Lot Number: 23HBI873
- Lot Number: 23IBR043
- Lot Number: 23KBF277
- Lot Number: 24ABQ959
- Medline Kit Number/SKU VASC1057: UDI/DI each 10889942431922
- UDI/DI case 40889942431923
- Lot Number: 25KMF194.
Distribution
Distributed nationwide across the United States.