Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PICC Kits Due to Endotoxins
Angiodynamics Inc. is recalling 15 boxes of RS TANDEM 5F DL BIOFLO PICC kits because components 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 classification is Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device constitutes a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 15 boxes of RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097. The recall is due to the possibility that a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 34 US states, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot numbers involved are 5303198 and 5320749, and the Universal Product Number is H96560M2500971.
Healthcare providers and consumers should check their inventory for these specific catalog 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
- RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 15
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 (3)
- UPN: H96560M2500971
- Lot: 5303198
- 5320749
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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