Baxter Healthcare Corporation — FDA Facility Profile
Baxter Healthcare Corporation is an FDA-registered facility (FEI 1314492) located in MEDINA, NY, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Apr 4, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (4 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 1, 2013
- Recalls as the recalling firm
- 10, latest Mar 19, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 4, 2025 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Sep 28, 2021 | No Action Indicated (NAI) | Design validation - software validation not performed (21 CFR 820.30(g)) |
| Aug 21, 2017 | No Action Indicated (NAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Aug 28, 2012 | Voluntary Action Indicated (VAI) | Report of risk to health (21 CFR 806.10(a)(1)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Dec 8, 2010 | Voluntary Action Indicated (VAI) | DHR content (21 CFR 820.184) Training records (21 CFR 820.25(b)) |
| Aug 31, 2010 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Documented evaluation (21 CFR 820.50(a)(1)) Process changes - review, evaluation and revalidation (21 CFR 820.75(c)) Time to report - 10 days (21 CFR 806.10(b)) and 1 more |
| Dec 22, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 19, 2021 | Class II | Z-1487-2021 | Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled… Potentially defective component in the AC power adapter which may fail over time. |
| Jan 6, 2021 | Class II | Z-1150-2021 | Infusion Pump Battery performance issues related to prolonged storage. |
| Sep 18, 2018 | Class II | Z-0107-2019 | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode… |
| Jun 21, 2018 | Class II | Z-1248-2019 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code… The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was… |
| May 8, 2018 | Class II | Z-2112-2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump… and 1 more product The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the… |
| Apr 3, 2018 | Class II | Z-1663-2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6)… and 4 more products Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed… |
| Oct 6, 2017 | Class II | Z-0971-2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN… Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion… |
| Jan 26, 2017 | Class II | Z-1693-2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code… SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout … |
| Apr 23, 2012 | Class III | Z-2030-2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software.
Product… Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it… |
| Jul 6, 2011 | Class I | Z-1490-2012 | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number… Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from… |
Facility details
- Company
- Baxter Healthcare Corporation
- Location
- MEDINA, NY (US)
- Source
- device