Severity
Moderate
ModerateClass IITerminated
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).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2382-2015) was formally reported on August 19, 2015, with the manufacturer initiating the action on June 16, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. B. Braun Interventional Systems is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 11 units.
The documented reason for this recall is: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537). Distribution data in the federal record shows the product reached: CA and NY only.. 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
11 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by B. Braun Interventional Systems. Units affected: 11 units.
Why was this product recalled? ▼
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2382-2015.
Where was the recalled product distributed? ▼
Distribution: CA and NY only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2382-2015) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 August 19, 2015. 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.