Recall Z-0793-03 ยท FRN Pump, Infusion
Abbott Laboratories
Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version
| Date | Apr 1, 2003 |
| Status | Terminated |
| Reason | Products contain software deficiencies which could allow over infusion thereby administering excess medication. |
| Root cause | Other |
| Action | On 4/1/03, the firm issued letters via Federal Express Overnight Delivery to all its direct consignees, informing them of the affected devices and providing instructions on the recall. |
| Quantity | 1310 units |
| Distribution | Product received nationwide distribution to approx. 120 direct consignees. The firm identified 3 Govt. accounts: (1) Nthrn VA Comm. Hospital, 601 S. Carlin Spg. Rd., Arlington VA 22204, (2) Veterans Admin Med Ctr., 4100 W. 3rd St., Dayton OH 45428, (3) GW University Hospital, 901 23rd St. NW # 5306 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974778 | ABBOTT GEMSTAR IV INFUSION PUMP Abbott Laboratories, Mar 17, 1998 |