Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implan
FDA device recall Z-1961-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- B. Braun Interventional Systems
- Reason for recall
- B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis
- Action taken
- B. Braun Interventional Systems, Inc. issued an "Urgent: Medical Device Recall" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted. For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 40 in US
- Distribution
- Nationwide Distribution -- NY.
- Date initiated
- 2009-06-22
- Date posted
- 2009-09-03
- Date terminated
- 2012-06-05
- Location
- Plymouth, 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/ CELSITE CONCEPT, ACCESS PORTS (K061424) | Aesculap, Inc. | 2006-07-31 |
| CELSITE VENOUS SYSTEM (K952548) | B.Braun Medical, Inc. | 1995-07-21 |