FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version
- Recall number
- Z-0792-03
- Recalling firm
- Abbott Laboratories
- Product
- Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version
- Status
- Terminated
- Initiated
- 2003-04-01
- Posted
- not on file
- Terminated
- 2003-10-09
- 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 # 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K974778"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2921482
- Firm city
- Morgan Hill
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28