Reported May 16, 2018 · Terminated
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 711 Park Ave · Medina, NY · 14103-1036
Is this the product you have?
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR
- Product UsageThe Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the
- following clinically accepted routesintravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming
- Lot codes and dates
- Serial numbers
61 of 61 codes
745365750241750330752814754975757930762405763117764490768855772652773031773134773520774413778845779430779822781545782706782985783185787001793146833195865842883498883854889556889775890230891398891421891647891689901881917897917963919594919736919837921078921819924734928406937123940345940860940949941786944619966019990542996435996823997156998126101122910115441014955
- Serial numbers
- Amount recalled
- 444 units in total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
This product could cause temporary or reversible health problems — stop using it.
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