Recall Z-1455-2014 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Gambro Renal Products, Incorporated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysi
| Date | Apr 11, 2014 (initiated Dec 9, 2013) |
| Status | Terminated |
| Reason | Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. |
| Root cause | Process control |
| Action | On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification. |
| Quantity | 306,525 sets (20435 boxes of 15 sets) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.