Angiodynamics Recalls RS TANDEM 5F DL XPP Kits Due to Endotoxins
Angiodynamics Inc. is recalling 7 units of RS TANDEM 5F DL XPP kits because components may contain unsafe levels of bacterial endotoxins.
What this means for you
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 risk of harm from bacterial endotoxins, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 7 units of the RS TANDEM 5F DL XPP, Catalog Number 60M019881. The recall is being conducted 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 for the recalled items is 5299857, and the Universal Product Number (UPN) is H96560M0198811.
Healthcare providers and facilities that have received these products should stop using them and contact the recalling firm for further instructions. Consumers who may have purchased these specific medical devices should contact their healthcare provider or the manufacturer to determine if they are affected.
The recalled product
- Product
- RS TANDEM 5F DL XPP, Catalog Number 60M019881
- 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 (2)
- UPN: H96560M0198811
- Lot: 5299857
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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