NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility
Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a potential sterility failure, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 8 boxes containing 25 units of the NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005. The recall involves Lot Number 5122528.
The recall was initiated because the product has the potential to be non-sterile, as it was not packaged in accordance with specification. This defect could compromise the sterility of the medical device.
The affected units were distributed to facilities in California, Kentucky, Maryland, Oregon, Virginia, and Texas. Users should stop using the product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Fluid Delivery
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 (1)
- Lot Number: 5122528
Distribution
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 · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateNAMIC Fluid Management Convenience Kits Recalled for Assembly Defect
FDA (Devices) · 2018-04-25
- HighMedline Namic Fluid Delivery Set Recalled for Lack of Sterility Assurance
FDA (Devices) · 2024-05-22
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kit Recalled for Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2015-03-04