SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
FDA device recall Z-2738-2014 · posted 2014-10-01 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- USA: 56 units, Canada: 2 units
- Distribution
- Worldwide Distribution -- USA and Canada.
- Date initiated
- 2014-09-03
- Date posted
- 2014-10-01
- Date terminated
- 2017-03-16
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY (K042121) | Sigma Intl. | 2004-08-26 |