Recall archive
200 recalls · page 5 of 9
Reported Nov 17, 2021
Hemodialysis Delivery System, Software Version 2.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the…
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a potential leak between the venous patient connector and patient's hemodialysis access.
FDA (openFDA device enforcement)
Reported May 5, 2021
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potentially defective component in the AC power adapter which may fail over time.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 10, 2021
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during…
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Infusion Pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Battery performance issues related to prolonged storage.
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
FDA (openFDA device enforcement)
Reported Feb 10, 2021
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential for the battery to lose its ability to be recharged.
FDA (openFDA device enforcement)
Reported Jan 20, 2021
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
FDA (openFDA device enforcement)
Reported Jan 13, 2021
MiniCap Extended Life PD Transfer Set
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential for no-flow and leaks under the twist clamp.
FDA (openFDA device enforcement)
Reported Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — There is a potential software error during programming.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 18, 2020
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — Presence of particulate matter in solution - black and transparent particles
FDA (openFDA drug enforcement)
Reported Oct 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product · Product details · Reason for recall — Baxter is updating the device IFU for safety communication regarding cleaning practices.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2020
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential disconnection of tubing set.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
Prismaflex Control Unit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
FDA (openFDA device enforcement)
Reported May 13, 2020
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sandoz, Inc.
Matched: Product details — Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
FDA (openFDA drug enforcement)
Reported May 6, 2020
Prismaflex System, Prismaflex Control Unit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2020
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
2 more products in this recall
FDA (openFDA device enforcement)
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