FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
- Recall number
- Z-2738-2014
- Recalling firm
- Baxter Healthcare Corp.
- Product
- SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
- Status
- Terminated
- Initiated
- 2014-09-03
- Posted
- 2014-10-01
- Terminated
- 2017-03-16
- Reason
- One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
- Root cause
- Equipment maintenance
- Action
- Initial notification was initiated via telephone call by the Baxter Medina Service Center on 8/28/14 to all affected Sigma SPECTRUM Infusion Pump consignees. URGENT DEVICE CORRECTION Letters (dated 9/03/2014) were sent to the consignees via USPS first class mail on 9/03/14 formally informing them of the recall. The letters identified the affected product, the description of the issue, the hazard involved, as well as, the actions to be taken by customer. Customers are being instructed to immediately remove the pump from use and return the pump to Baxter for inspection. The firm will provide replacements. Customers are to contact Baxter Healthcare Medina at 800-356-3454 for technical questions regarding the letter.
- Quantity
- USA: 56 units, Canada: 2 units
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.
- 510(k) numbers
- ["K042121"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- 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