🔍 RecallPedia

ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO

Class I - Dangerous
🏥 Medical Devices Recalled: November 27, 2018 ICU Medical Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099
  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:
ICU Medical, Inc.
Reason for Recall:
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO

Product Codes/Lot Numbers:

Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099

Distribution:

Distributed in: CA, TX, WI, NY, NC, GA, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1071-2019

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