Angiodynamics RS 5F DL XPP Kits Recalled for Bacterial Endotoxins
Angiodynamics Inc. is recalling RS 5F DL XPP kits because a component 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. According to the rubric, FDA Class II recalls with potential for significant injury (unsafe levels of pyrogens) are categorized as Severe.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 7 boxes of RS 5F DL XPP kits, Catalog Number 60M030393. 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 and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5304317, and the Universal Product Number (UPN) is H96560M0303931.
Healthcare providers and facilities should stop using the affected kits and contact the recalling firm for instructions on how to return or dispose of the products.
The recalled product
- Product
- RS 5F DL XPP, Catalog Number 60M030393
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 7
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: H96560M0303931
- Lot: 5304317
- 5304317
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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