Bard Access Systems Recalls Low Profile Ports with Undersized Catheters
Bard Access Systems is recalling Low Profile Ports with 6.6 Fr catheters because some silicone catheters may be undersized to 5.3 Fr.
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 hazard involves a dimensional discrepancy (undersized catheter) rather than a high-risk pathogen or structural failure, and no injuries or illnesses are reported in the source text.
Plain-English summary
Bard Access Systems is recalling various Low Profile Ports with 6.6 Fr Single Lumen Broviac Catheters. The recall involves 200 units of the Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter, specifically Lot REXC0467.
The recall is being conducted because a small number of the silicone catheters may be undersized to 5.3 Fr instead of the 6.6 Fr stated in the device labeling. These products are used for patient therapies requiring repeated access to the vascular system, including the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products.
The affected products were distributed worldwide, including the United States, Belgium, and Canada. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in…
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Implanted Port
- Affected units
- 200
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)
- Lot REXC0467
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bard Access Systems 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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