Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip
Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
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 2/5 (Moderate).
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 stated hazard is a prolongation of the operation due to a component mismatch, which represents a procedural inconvenience rather than a direct risk of serious injury or death.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 598 units of the Vaccess CT Power-Injectable Implantable Port with Suture Plugs (Ref: 7496000). The recall affects specific lots (RECR0929, RECR1511, RECR1882) distributed worldwide, including the United States and various international regions.
The firm identified that the product may incorrectly contain a tunneler with a barb tip designed for a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This manufacturing error can result in a prolongation of the surgical operation.
Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of…
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 598
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)
- Lot # RECR0929
- RECR1511
- RECR1882
Distribution
Part of a larger recall action
This product is one of 10 recalled by Bard Peripheral Vascular 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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