🔍 RecallPedia

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

Class I - Dangerous
🏥 Medical Devices Recalled: December 30, 2014 Clinical Innovations Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
  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:
Clinical Innovations, LLC
Reason for Recall:
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

Product Codes/Lot Numbers:

Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1014-2015

Related Recalls

Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. -VPSU15032250, 1mL vial, bagged qty 250

Clinical Innovations

Class I - Dangerous

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Jul 19, 2022 Beverages Nationwide View Details →

Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptically packaged in 15 mL cups with foil lid. Each cup contains 15 mL of USP purified water, 24% sugar, citric acid (buffer). Cup is latex-free, DEHP-free, BPA-free. UPC 00814247020673. Store at room temperature. Product is only used in the hospital setting including the NICU and administered directly to tongue or buccal surface.

Clinical Innovations

Class I - Dangerous

Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.

Jul 19, 2022 Beverages Nationwide View Details →

Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314

Clinical Innovations

Class I - Dangerous

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Jul 19, 2022 Beverages Nationwide View Details →