🔍 RecallPedia

Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2012 Impact Instrumentation Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Impact Instrumentation, Inc.
Reason for Recall:
Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

Product Codes/Lot Numbers:

Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2152-2012

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