Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 29, 2014
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 BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, bl
Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Access Systems recalled Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Cathe… - a moderate-severity action.
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Cathe… was recalled by Bard Access Systems in January 29, 2014. Reason: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a…. Check the official notice for the remedy. Verify recall #Z-0815-2014 with the FDA Devices before acting.
The recall
Bard Access Systems issued this moderate-severity FDA Devices recall-Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a….
- Moderate
- severity level
- 200 units
- affected scope
- Class II
- classification
- January 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0815-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0815-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on December 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Access Systems is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 200.
The documented reason for this recall is: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labe… Distribution data in the federal record shows the product reached: Worldwide Distribution - US nationwide, Belgium, and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
200
Related Recalls
6
3 from same agency
Product description
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 BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
Reason for recall
Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0815-2014 |
| Date reported | January 29, 2014 |
| Date initiated | December 6, 2013 |
| Recalling firm | Bard Access Systems |
| Firm location | Salt Lake City, UT |
| Affected scope | 200 |
| Distribution | Worldwide Distribution - US nationwide, Belgium, and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0815-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.. Recalled by Bard Access Systems. Units affected: 200.
Why was this product recalled? ▼
Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0815-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US nationwide, Belgium, and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0815-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 29, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.