Angiodynamics Recalls RS 5F DL XCELA PICC Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling RS 5F DL XCELA PICC 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 potential contamination hazard (bacterial endotoxins) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 6 boxes of RS 5F DL XCELA PICC kits, Catalog Number 60M122272. 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, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5312021 and the UPN is M00160M1222721.
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 XCELA PICC, Catalog Number 60M122272
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 6
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: M00160M1222721
- Lot: 5312021
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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