Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PASV Catheters
Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters 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 is classified as FDA Class II and involves a high-risk pathogen (bacterial endotoxins) without reported illnesses, which aligns with 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 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters, Catalog Number 60M232242. The recall involves specific lots identified as 5304324 and 5316020, with the UPN H96560M2322421.
The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins, also known as pyrogens. The FDA has classified this as a Class II recall.
The affected products were distributed to numerous US states, including AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were also distributed to Canada, China, Ireland, and Spain. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 20
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: H96560M2322421
- Lot: 5304324
- 5316020
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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