Bard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters
Bard Access Systems is recalling MRI Low Profile Single Lumen ports because some silicone catheters may be undersized to 5.3 Fr instead of the labeled 6.6 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, and the hazard involves a dimensional discrepancy (undersized catheter) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Access Systems is recalling MRI Low Profile Single Lumen ports with Open-Ended 6.6Fr Silicone Catheters (Product Code 0603880). The recall involves 1,358 units from lots REXC0931 and REXC0736. 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 recall was initiated 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. The affected products were distributed worldwide, including the United States, Belgium, and Canada.
Healthcare providers and patients should contact Bard Access Systems for further instructions regarding the recall and replacement of affected devices.
The recalled product
- Product
- MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product 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 BardPort…
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Implanted Port
- Affected units
- 1,358
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 REXC0931 and REXC0736
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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