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High RiskFDAfda-Z-0058-2013ELECTRICAL SHOCK

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

Units Affected
2,913
Recall Date
September 25, 2012
Issuing Agency
Hazard
Electrical Shock

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0058-2013.

Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0058-2013.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0058-2013.

Belmont Instrument Corporation

FDA

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Belmont Instrument Corporation Recall FAQ

Belmont Instrument Corporation is the subject of a medical devices safety report: Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.. The notice was published on September 25, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 2,913 units are potentially affected.