Baxter Healthcare Corporation recalls The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream…
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Classification
- Class I
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-08-30
USBaxter Healthcare Corporation recalls Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare…
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- 2023-07-26
- US
Baxter Healthcare Corporation recalls GEM FLOW COUPLER Monitor, PN 5156-00000-011
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active…
- 2023-07-19
- US
Baxter Healthcare Corporation recalls Allen Advance Chest Support with Pad
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice → - 2023-07-05
- US
Baxter 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 →
Other drugs & medical recalls in the United States
- 2023-07-19
- US
Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
FDA · DeviceAbbottWorldwide distribution - US Nationwide and the countries of Slovakia, Czech…Official notice → - US
Baxter Healthcare Corporation recalls Allen Advance Chest Support with Pad
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice → - US
Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
FDA · DeviceOsteomed, LLCWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS,…Official notice → - US
Draeger Medical, Inc. recalls Oxylog 3000 Plus emergency and transport ventilator
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
FDA · DeviceDraeger Medical, Inc.Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra,…Official notice → - US
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured…
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- US
Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle,…
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
FDA · DrugGlobal Pharma Healthcare Private LimitedProduct was distributed to two distributors who further distributed Nationwide…Official notice →