Angiodynamics Recalls Bioflo Midline Catheters Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters 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 agency classified this as a Class II recall. The presence of unsafe levels of bacterial endotoxins in a medical device poses a significant risk of adverse health consequences, fitting the 'Severe' criteria for significant injury risk or high-risk contamination.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters, Catalog Number 60M035472. 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 5312194, and the Universal Product Number (UPN) is H96560M0354721.
Healthcare providers and consumers should stop using these specific devices and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
- Affected units
- 3
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: H96560M0354721
- Lot: 5312194
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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