AngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
AngioDynamics is recalling specific lots of Smart Port CT-Implantable Port kits due to potential compromised sterility. The recall affects 267 kits distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (compromised sterility of an implantable device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
AngioDynamics, Inc. is recalling specific batches of Smart Port CT-Implantable Port kits and Valved introducers. The recall is being conducted because these specific devices may have a potential for compromised sterility. The affected products are identified by Catalogue Numbers CT96STSD-VI and CT96STSA-VI, with specific lot numbers 5616651, 5647359, 5654135, and 5654129. No other products are affected by this recall action.
The recall involves 267 kits that were distributed nationwide in the United States. The distribution covered 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. These devices are indicated for patients requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, and blood products, as well as for sampling blood and power injection of contrast media for imaging.
Healthcare providers and patients should verify if they possess the specific lot numbers listed in the recall notice. If the affected devices are in use, they should contact the manufacturer or their medical provider for instructions on replacement or removal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 267
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 (5)
- UPN: H787CT96STSDVI1
- Lot #: 5616651
- 5647359
- 5654135 UPN: H787CT96STSAVI1
- Lot #: 5654129
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.
See all 2 products in this recall →Related recalls
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