Recall Z-0637-2007 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cook, Inc.
COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
| Date | Mar 16, 2007 (initiated Jan 2, 2007) |
| Status | Terminated |
| Reason | These catheters do not include the proximal sidehole as required by the specification. |
| Root cause | Other |
| Action | Consignees were notified by phone on 1/2/07 and instructed to return the product. |
| Quantity | 100 |
| Distribution | Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950118 | ABRM CATHETER Cook, Inc., Feb 8, 1996 |