Angiography/angioplasty Kit
Recall Summary Medline is recalling three angiography/angioplasty medical kits (SKU numbers DYNJ23532C, DYNJ65185, and VASC1057) because particles have been found in the fluid pathways of the Namic Manifold components included in these kits. These kits were distributed nationwide across the United States and internationally to several countries. The recall affects medical facilities that received these products.
- 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.
- Reason
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bf01e530-38c5-400b-a3bc-ffc79e2daadf