AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a significant risk (compromised sterility) falls under the 'Severe' category (Score 4), particularly given the potential for serious injury from infection.
Plain-English summary
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Safe Sheath Ultralite Vascular Introducer/Catheter Introducer kits (Catalogue #: VI10, Lot #: DP-11759). The recall is being conducted because the devices may have a potential for compromised sterility. The product is used for the introduction of various types of pacing leads and catheters.
The recall involves 337 units, consisting of 14 boxes of 5 and 267 units per kit. These products were distributed nationwide in the United States, specifically in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, and WA. No other products or lots are affected by this recall action.
Healthcare facilities and consumers should stop using the affected products and contact AngioDynamics for further instructions or a return.
The recalled product
- Product
- AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Vascular Access
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: VI10
- Lot #: DP-11759
Distribution
Part of a larger recall action
This product is one of 2 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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