FDA Devices recall · Reported August 19, 2015
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low p
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
B. Braun Interventional Systems recalled Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port… - a moderate-severity action.
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port… was recalled by B. Braun Interventional Systems in August 19, 2015. Reason: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for …. Check the official notice for the remedy. Verify recall #Z-2382-2015 with the FDA Devices before acting.
The recall
B. Braun Interventional Systems issued this moderate-severity FDA Devices recall-The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for ….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- August 19, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2382-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
Reason for recall
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2382-2015 |
| Date reported | August 19, 2015 |
| Date initiated | June 16, 2015 |
| Recalling firm | B. Braun Interventional Systems |
| Firm location | Minneapolis, MN |
| Affected scope | 11 units |
| Distribution | CA and NY only. |
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-2382-2015) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026