🔍 RecallPedia

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

Class I - Dangerous
🏥 Medical Devices Recalled: April 7, 2015 Catheter Research Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Model Number/Catalogue/Product Number: TMI1160; 61-5205; TMI1198; KM61-5205; 61-3205; Lot codes: J436A, J436B, J436C, J436D; J437A, J437B, J437C, J437D; Exp. J436 (2017-03); J437 (2017-03)
  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:
Catheter Research, Inc
Reason for Recall:
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

Product Codes/Lot Numbers:

Model Number/Catalogue/Product Number: TMI1160; 61-5205; TMI1198; KM61-5205; 61-3205; Lot codes: J436A, J436B, J436C, J436D; J437A, J437B, J437C, J437D; Exp. J436 (2017-03); J437 (2017-03)

Distribution:

Distributed in: MN, CA, OH, IL, FL, MA, WI, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1481-2015