🔍 RecallPedia

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Class I - Dangerous
🏥 Medical Devices Recalled: July 22, 2019 GETINGE US SALES Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988
  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:
GETINGE US SALES LLC
Reason for Recall:
Reversed expiration and manufacturing date on the label
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Product Codes/Lot Numbers:

Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2433-2019

Related Recalls

The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

GETINGE US SALES

Class I - Dangerous

Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).

Aug 22, 2019 Implants & Prosthetics View Details →

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

GETINGE US SALES

Class I - Dangerous

The monitor displays an error message . The error message states "internal error restart or service".

Jun 5, 2019 Diagnostic Equipment Nationwide View Details →