ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introduce
FDA device recall Z-0871-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Deltec, Inc
- Reason for recall
- Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
- Action taken
- A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJT
- Distribution
- The recalled products were shipped nationwide in the United States and worldwide.
- Date initiated
- 2004-03-29
- Date posted
- 2004-07-20
- Date terminated
- 2006-12-28
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (K994216) | Sims Deltec, Inc. | 2000-01-27 |