Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Read the official notice →- Date
- 2023-05-03
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare…
- Classification
- Class II
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Baxter Healthcare recalls
- 2023-07-05
USBaxter Healthcare Corporation recalls NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.Official notice →- 2023-05-10
- US
Baxter Healthcare Corporation recalls Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g)…
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Qatar.Official notice → - 2023-05-03
- US
Baxter Healthcare Corporation recalls GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral…
The product is brittle and potentially crumbling upon handling or when being removed from its package.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of China, Germany,…Official notice → - 2023-04-26
- US
Baxter Healthcare Corporation recalls ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
- 2023-04-05
- US
Baxter Healthcare Corporation recalls Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA · DeviceBaxter Healthcare CorporationUS distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.Official notice → - 2023-03-15
- US
Baxter Healthcare Corporation recalls Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal…
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in…
Other drugs & medical recalls in the United States
- 2023-05-03
- US
SCA Pharmaceuticals recalls Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC#…
Subpotent Drug: Out of specification results for low potency was obtained.
- US
- US
DuPont Nutrition USA, Inc recalls Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont…
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
FDA · DrugDuPont Nutrition USA, IncNationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi…Official notice → - US
Wellness BioSciences recalls CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Marketed Without an Approved NDA/ANDA
- US
Methapharm Inc recalls Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral…
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
- 2023-04-26
- US
Baxter Healthcare Corporation recalls ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.