Angiodynamics Recalls Xcela Maximal Barrier Nursing Kits Due to Endotoxins
Angiodynamics Inc. is recalling Xcela 5FDL-55cm Maximal Barrier Nursing Kits because a component 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) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 99 boxes of Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003. 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 34 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lots involved are 5301074, 5304327, and 5308920, with UPN H965750031.
Healthcare providers and consumers should check their inventory for these specific catalog numbers and lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Nursing Kits
- Hazard
- Affected units
- 99
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 (4)
- UPN: H965750031
- Lot: 5301074
- 5304327
- 5308920
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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