Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling BioFlo Midline 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 criteria for a High severity score.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 190 boxes of BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490. 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 5302405, 5312036, and 5314940, with UPN H965464901.
Healthcare providers and consumers should check their inventory for these specific catalog numbers and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from which it was purchased.
The recalled product
- Product
- BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 190
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: H965464901
- Lot: 5302405
- 5312036
- 5314940
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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