Recall archive
200 recalls · page 6 of 9
Reported Mar 11, 2020
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
FDA (openFDA device enforcement)
Reported Feb 5, 2020
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Reason for recall — ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare…
FDA (openFDA device enforcement)
Reported Jan 15, 2020
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2019
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Product has the potential to leak.
FDA (openFDA drug enforcement)
Reported Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2019
TherMax Blood Warmer Unit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a…
FDA (openFDA device enforcement)
Reported Oct 30, 2019
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential ability to leak once used for compounding.
FDA (openFDA device enforcement)
Reported Oct 16, 2019
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
FDA (openFDA device enforcement)
Reported Oct 9, 2019
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette…
FDA (openFDA device enforcement)
Reported Sep 4, 2019
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
FDA (openFDA device enforcement)
Reported Jul 31, 2019
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Bags have potential to leak.
FDA (openFDA drug enforcement)
Reported Jul 10, 2019
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Failed Stability Specifications
FDA (openFDA drug enforcement)
Reported May 8, 2019
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for…
FDA (openFDA device enforcement)
Reported Feb 27, 2019
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
FDA (openFDA drug enforcement)
Reported Jan 2, 2019
GEM Coupler Forceps, GEM4183C, packaged individually.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential presence of rust on Coupler Forceps (GEM4183C).
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
FDA (openFDA drug enforcement)
Reported Nov 7, 2018
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Potential ability to leak once used for compounding.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2018
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — 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, the…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24),…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
FDA (openFDA drug enforcement)
Reported Sep 26, 2018
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — cGMP Deviation
FDA (openFDA drug enforcement)
Reported Sep 5, 2018
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details · Reason for recall — Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 15, 2018
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
Matched: Brand — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
2 more products in this recall
FDA (openFDA drug enforcement)
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