Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of significant injury from unsafe endotoxin levels.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 11 boxes of RS 5F DL BIOFLO PASV kits, Catalog Number 60M181578. The recall is due to a potential safety issue where a component of the kits might contain unsafe levels of bacterial endotoxins, also known as pyrogens.
The affected products are identified by Lot numbers 5303172 and 5310562, and UPN H96560M1815781. These kits were distributed to facilities in 34 US states, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- RS 5F DL BIOFLO PASV, Catalog Number 60M181578
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Surgical Kits
- Affected units
- 11
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: H96560M1815781
- Lot: 5303172
- 5310562
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.
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