Angiodynamics Recalls Microintroducer Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 86 boxes of Microintroducer Kits because a component may contain unsafe levels of bacterial endotoxins.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves unsafe levels of bacterial endotoxins, which is a significant risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 86 boxes of Microintroducer Kits, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901. The recall is being conducted because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 34 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lots involved are G18012001 and G18064125, with UPN H965459011.
Healthcare providers and consumers should stop using the affected kits and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 86
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 (3)
- UPN: H965459011
- Lot: G18012001
- G18064125
Distribution
Part of a larger recall action
This product is one of 38 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) 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.
See all 38 products in this recall →Related recalls
Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)
See all →- ModerateXcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
Same hazard · bacterial endotoxins
See all →- HighGalt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins
FDA (Devices) · 2018-08-08
- HighGalt Medical Elite HV Introducer Recalled for Bacterial Endotoxins
FDA (Devices) · 2018-08-08
- HighGalt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins
FDA (Devices) · 2018-08-08
- HighVascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins
FDA (Devices) · 2018-06-27
- SevereAngiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
FDA (Devices) · 2018-06-20