Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 2 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 agency classified this as an FDA Class II recall. Under the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the presence of unsafe bacterial endotoxins in a medical device constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 2 boxes of RS 5F DL BIOFLO PASV kits, Catalog Number 60M132324. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 33 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5312922 and the UPN is H96560M1323241.
Healthcare providers and consumers should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- RS 5F DL BIOFLO PASV, Catalog Number 60M132324
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- 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: H96560M1323241
- Lot: 5312922
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
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