CanadaMedline convenience kits containing Namic Angiographic Star Off Handle Manifolds are affected, including Namic Convenience Kit (model 60716233: lots 103572, 140414, 187932; model 60701816: lots 107115, 110268; model 60780115: lots 97460, 103526, 104349, 106356, 107916), Namic Custom Angiographic Kit (models 60701103, 60701152 — contact manufacturer for lot numbers), and Clot Retrieval Pack (model DYNJ56140C: lots 26CBE251, 26ABK843, 25HBV231). They were recalled because particulate was identified within the manifold fluid path, which could be introduced into blood circulation and become lodged in vessels, risking tissue or organ ischemia or death. Customers are directed to remove and destroy all manifolds; over‑labels will be provided for affected kits on hand stating the manifolds must be removed and discarded from further use.
What's being recalled
Companies: Medline Industries, LP, Three Lakes Drive, Northfield, Illinois, United States, 60093.
How to identify it
Affected products: Namic Convenience Kit; Lot or serial number: 103572; Model or catalogue number: 60716233
Affected products: Namic Convenience Kit; Lot or serial number: 140414; Model or catalogue number: 60716233
Affected products: Namic Convenience Kit; Lot or serial number: 187932; Model or catalogue number: 60716233
Affected products: Namic Convenience Kit; Lot or serial number: 107115; Model or catalogue number: 60701816
Affected products: Namic Convenience Kit; Lot or serial number: 110268; Model or catalogue number: 60701816
Affected products: Namic Convenience Kit; Lot or serial number: 97460; Model or catalogue number: 60780115
Affected products: Namic Convenience Kit; Lot or serial number: 103526; Model or catalogue number: 60780115
Affected products: Namic Convenience Kit; Lot or serial number: 104349; Model or catalogue number: 60780115
Affected products: Namic Convenience Kit; Lot or serial number: 106356; Model or catalogue number: 60780115
Affected products: Namic Convenience Kit; Lot or serial number: 107916; Model or catalogue number: 60780115
Affected products: Namic Custom Angiographic Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 60701103
Affected products: Namic Custom Angiographic Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 60701152
Affected products: Clot Retrieval Pack; Lot or serial number: 26CBE251; Model or catalogue number: DYNJ56140C
Affected products: Clot Retrieval Pack; Lot or serial number: 26ABK843; Model or catalogue number: DYNJ56140C
Affected products: Clot Retrieval Pack; Lot or serial number: 25HBV231; Model or catalogue number: DYNJ56140C
The hazard
Medline Industries is issuing a recall for specific item(s) and lot(s) of Medline convenience kits that contain Namic Angiographic Star Off Handle Manifolds. Medline has identified the presence of particulate within the fluid path of the manifolds. Particulate within the manifold fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. This carries a risk of serious injury, such as tissue or organ ischemia, or death.
What to do
Customers are directed to remove and destroy all manifolds. Over-labels will be provided for any affected kits on hand stating that the affected manifolds must be removed and discarded from further use.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States