Drugs & medicalClass II

Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the…

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Read the official notice →
Date
2022-11-09
Country
United States
Brand
Baxter Healthcare
Product
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients…
Classification
Class II
Units
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2022-12-28
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    Baxter Healthcare Corporation recalls Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

    Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

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    Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by…

    Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

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  4. 2022-11-23
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    Baxter Healthcare Corporation recalls Hill-Rom Progressa Bed System

    The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur…

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  6. 2022-11-09
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    Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

    Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin…

    FDA · DeviceBaxter Healthcare CorporationUSOfficial notice →
  8. 2022-10-19
  9. US
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    Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

    Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight…

    FDA · DeviceBaxter Healthcare CorporationUS NationwideOfficial notice →
  10. 2022-10-05
  11. US
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    Baxter Healthcare Corporation recalls Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts…

    Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

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All 123 Baxter Healthcare recalls →

Other drugs & medical recalls in the United States

  1. 2022-11-16
  2. US
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    SEDECAL SA recalls Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

    Due to un-commanded movement of mobile x-ray unit.

    FDA · DeviceSEDECAL SAU.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY,…Official notice →
  3. US
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    Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

    The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

    FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA…Official notice →
  4. US
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    Viatris Inc recalls Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only,…

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  5. 2022-11-09
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    During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

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    Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may…

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