Z-1667-2018Class II

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE

Name: Z-1667-2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE
Creator: Baxter Healthcare Corporation
Published: 2018-04-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-04-03 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug... on 2018-04-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1667-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-03
Posted: 2018-05-04
Terminated: 2020-02-14
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The 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 routes: intravenous, 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.
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail. Actions to be Taken by Customers: 1. Locate and discontinue use of all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to [email protected] even if you do not have inventory. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
Quantity in commerce: 444 units in total
Distribution: US Nationwide & Puerto Rico
Product codes and lots: Serial number 758477

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1667-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1663-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1664-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1665-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1666-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1667-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code FRN

K042121Class IISpectrum and Spectrum with Master Drug LibrarySigma Intl. / cleared 2004-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)