Recall Z-0543-04 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Abbott Laboratories HPD/ADD/GPRD
18 Gauge thin wall needle as part of a Central Venous Catheter Kit
| Date | Feb 24, 2004 (initiated Dec 17, 2003) |
| Status | Terminated |
| Reason | 18 gauge needles in Central Venous Catheter kits may be partially occluded. |
| Root cause | Other |
| Action | Consignees were notified by FedEx letter on 12/17/2003. |
| Quantity | 93564 |
| Distribution | Nationwide including VA facilities in ID and NC. Foreign distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Columbia, Dominican Republic, Egypt, Greece, Ireland, Italy, Japan, Malaysia, Portugal, Slovenia, Spain, Switzerland, Turkey, UK, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961552 | CVP POLYURETHANE CATHETER Abbott Laboratories, Feb 10, 1997 |