Z-0794-03

Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version

Name: Z-0794-03 Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version
Creator: Abbott Laboratories
Published: 2003-04-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-04-01 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version on 2003-04-01. The reason FDA records is "Products contain software deficiencies which could allow over infusion thereby administering excess medication". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0794-03
Status: Terminated
Initiated: 2003-04-01
Posted: 2015-06-25
Terminated: 2003-10-09
Recalling firm: Abbott Medical
Product: Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version
Product code: FRN Pump, Infusion
Reason for recall: Products contain software deficiencies which could allow over infusion thereby administering excess medication.
Root cause tag: software
FDA 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 in commerce: 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 # 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.
Product codes and lots: All serial numbers

Product code FRN

K974778Class IIAbbott Gemstar IV Infusion PumpAbbott Laboratories / cleared 1998-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)