Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two
FDA device recall Z-0059-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK
- Action taken
- The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 290 kits
- Distribution
- The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.
- Date initiated
- 2004-09-27
- Date posted
- 2004-10-28
- Date terminated
- 2004-11-30
- 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 |
|---|---|---|
| ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K993691) | Arrow Intl., Inc. | 2000-03-08 |