Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) . Product
FDA device recall Z-0255-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
- Action taken
- The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall').
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 913
- Distribution
- Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern port
- Date initiated
- 2003-11-04
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-12
- Location
- Mount Holly, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTROSTAT LEAD INTRODUCER (K960200) | Msi, Inc. | 1996-07-02 |
| THEREX LOW-PROFILE PORT-TITANIUM (K934802) | Therex Corp. | 1994-03-22 |
| THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM (K933316) | Therex Corp. | 1994-02-23 |
| A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM (K921475) | Therex Corp. | 1992-10-16 |