Angiodynamics Recalls RS 5F DL BIOFLO PICC Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 12 boxes of RS 5F DL BIOFLO PICC kits because a component may contain unsafe levels of bacterial endotoxins.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of significant injury from unsafe levels of bacterial endotoxins in a medical device.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 12 boxes of RS 5F DL BIOFLO PICC kits, Catalog Number 60M071831. 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 5310191 and the Universal Product Number (UPN) is H96560M0718311.
Healthcare providers and consumers should stop using the affected kits and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- RS 5F DL BIOFLO PICC, Catalog Number 60M071831
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 12
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: H96560M0718311
- Lot: 5310191
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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