Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems)
FDA device recall Z-2382-2015 · posted 2015-08-13 · Terminated
Recall details
- Recalling firm
- B. Braun Interventional Systems
- Reason for recall
- The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
- Action taken
- An Urgent Medical Device Recall letter, dated 6/16/2015 was sent to the 2 consignees via express mail. The letter explained the issue and requested the hospital review their inventory for the affected model and lot. If any quantities of the lot remained in inventory, the product was to be returned to BIS. A BIS sales representative will personally visit each account and complete an inventory sheet. Customers with questions can contact Paul O-Connell, President at 1-847-274-0097
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 11 units
- Distribution
- CA and NY only.
- Date initiated
- 2015-06-16
- Date posted
- 2015-08-13
- Date terminated
- 2015-11-20
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELSITE IMPLANTABLE ACCESS PORT SYSTEMS (K130576) | B. Braun Interventional Systems, Inc. | 2013-04-02 |