Celsite Implantable Access Port System recall: Endotoxin
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and…
Why was Celsite Implantable Access Port System recalled?
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: 36896615
- Product
- Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and…
- Recalling firm
- B. Braun Interventional Systems
- Quantity
- 11 units
- Distribution
- CA and NY only.
- Recall date
- August 19, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)