Recalls / —

—#27007

Product

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

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K974778

Affected lot / code info

All serial numbers

Why it was recalled

Products contain software deficiencies which could allow over infusion thereby administering excess medication.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Abbott Laboratories

Address

755 Jarvis Drive, Morgan Hill, California 95037

Distribution

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.

Timeline

Recall initiated

2003-04-01

Terminated

2003-10-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.