Baxter SPECTRUM Pump Recall Due to Service Technician Error
Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for intravenous fluid administration where a service error could impact patient safety, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling SPECTRUM Pumps, Model No. 35700BAX, which are intended for the controlled administration of intravenous fluids. The recall involves 56 units in the United States and 2 units in Canada.
The recall was initiated because one service technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the period of May 5, 2014, through June 3, 2014. The affected units are identified by specific software versions (5.02.06, 6.02.06, and 6.02.11) and a list of serial numbers provided in the official notice.
Hospitals and healthcare facilities should check their inventory for the affected serial numbers and software versions. Users should contact Baxter Healthcare Corp. for instructions on how to address the potential service error.
The recalled product
- Product
- SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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