🔍 RecallPedia

RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2014 Smith & Nephew Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Model #'s 66800059, all lots since product launched 01/16/2009
  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:
Smith & Nephew, Inc.
Reason for Recall:
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

Product Codes/Lot Numbers:

Model #'s 66800059, all lots since product launched 01/16/2009

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2688-2014

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META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

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