Recall Z-0084-04 ยท KZH Introducer, Syringe Needle
Arrow International Inc
Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm
| Date | Nov 1, 2003 (initiated Sep 16, 2003) |
| Status | Terminated |
| Reason | wrong product in box |
| Root cause | Other |
| Action | The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product. |
| Quantity | 34 units |
| Distribution | The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) Diatek, Inc., Aug 14, 2001 |