10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
FDA device recall Z-0088-04 · posted 2003-11-01 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- package lid identifies the contents incorrectly
- Action taken
- The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KZH
- Quantity affected
- 80 units
- Distribution
- The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka
- Date initiated
- 2003-10-22
- Date posted
- 2003-11-01
- Date terminated
- 2004-04-05
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET (K924607) | Arrow Intl., Inc. | 1993-04-22 |