Angiodynamics Recalls PICC Nursing Trays Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.
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: The agency classification is FDA Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays, Catalog Number 60M700936. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 34 US states, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5316398, and the Universal Product Number (UPN) is H96560M7009361.
Healthcare facilities and consumers who have these specific trays should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line Kit
- Affected units
- 2
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 (2)
- UPN: H96560M7009361
- Lot: 5316398
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 endotoxin
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
FDA (Devices) · 2025-04-02
- HighShoulder implant recalled due to excessive bacterial endotoxin
FDA (Devices) · 2024-09-25
- HighCook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels
FDA (Devices) · 2024-05-22
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22