Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version
FDA Recall Z-0793-03 · Posted None
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeFRN
Date Initiated2003-04-01
Date Terminated2003-10-09
Product Quantity1310 units
Reason for Recall
Products contain software deficiencies which could allow over infusion thereby administering excess medication.
Firm 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.
Root Cause
Other
Distribution Pattern
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 # 5306N, Washington DC 20037. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians and nurses who received the recalled product. There is no known Canadian distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.