Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect
Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a procedural delay due to a dimensional defect rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 582 units of XCELA, 8F Single Plastic Port Filled, Valved, UPN H965440400, Cat. No. 44-040. These devices are used for long-term access to the central venous system for administering fluids, chemotherapy, and other therapies, as well as for blood specimen withdrawal.
The recall was initiated because the snap lock connectors provided within the implantable port kits may not meet dimensional specifications. This defect prevents the catheter from being inserted into the snap lock connector prior to connection to the port chamber, which results in a delay to the implantation procedure.
The affected products were distributed worldwide, including nationwide in the United States in the states of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, and WI, as well as in Canada. Healthcare providers and patients should contact the manufacturer for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood product
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 582
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 (1)
- 5480564
Distribution
Part of a larger recall action
This product is one of 5 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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