Celsite Implantable Access Port System — Class II medical device recall Z-2382-2015
Terminated recall by B. Braun Interventional Systems, reported 2015-08-19, distributed in CA, NY. The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for t
| Recall number | Z-2382-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Interventional Systems, Minneapolis, MN, United States |
| Recall initiated | 2015-06-16 |
| Classified | 2015-08-13 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2015-11-20 |
| Distributed | CA, NY |
| Quantity | 11 units |
| Reason classes | sterility, specification failure |
| Lot numbers | 36896615 |
| Model numbers | T301 |
Product
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2382-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.