Recall Z-0059-05 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
| Date | Oct 28, 2004 (initiated Sep 27, 2004) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Mar 8, 2000 |