🔍 RecallPedia

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Class I - Dangerous
🏥 Medical Devices Recalled: July 31, 2015 Edward Lifesciences Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31 59999004 3/13/2017 PXVMP2X31 59999006 3/13/2017 PXVMP3X31 59994223 3/13/2017 PXVMP3X31 60049581 4/23/2017 PXVMP3X32 60025874 3/31/2017 T001746A 60036771 4/30/2017 T001759A 59976102 3/10/2017 T001759A 60014134 3/31/2017 T001759A 60020177 4/13/2017 T001759A 60049570 5/4/2017 T330V11A 60014160 3/29/2017 T333F00A 59987991 3/9/2017 T333F00A 60001468 3/16/2017 T333F00A 60022033 3/13/2017 T334041A 60008925 3/25/2017 T334041A 60049612 5/5/2017 T336547B 60008919 3/27/2017 T337305B 59987992 3/11/2017 T337305B 60001473 3/17/2017 T391314A 60020222 3/29/2017 T391T01A 60014163 3/30/2017 T395606B 60022034 3/13/2017 T395606B 60025971 4/14/2017 T430140A 60014177 3/31/2017 T430609A 60001486 3/16/2017 T430609A 60043616 4/27/2017 T431305A 60008942 3/25/2017 T431305A 60059909 5/8/2017 T440B20B 59994257 3/13/2017 T440B20B 60030953 4/17/2017 T440B21A 60025987 4/15/2017 T440B21A 59976182 3/11/2017 T440B26B 60030938 4/17/2017 T440B26B 60049616 5/4/2017 T443422A 60036750 4/29/2017 T443422A 60020223 4/15/2017 T449103B 60008929 3/24/2017 T449103B 60043599 4/28/2017 T450544A 60030944 4/20/2017 T494C00B 60020168 3/19/2017 T494C00B 60001415 3/25/2017 T494C00B 60043543 4/21/2017 T530116B 60022035 3/13/2017 T530116B 60008937 3/24/2017
  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:
Edward Lifesciences, Llc
Reason for Recall:
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Product Codes/Lot Numbers:

Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31 59999004 3/13/2017 PXVMP2X31 59999006 3/13/2017 PXVMP3X31 59994223 3/13/2017 PXVMP3X31 60049581 4/23/2017 PXVMP3X32 60025874 3/31/2017 T001746A 60036771 4/30/2017 T001759A 59976102 3/10/2017 T001759A 60014134 3/31/2017 T001759A 60020177 4/13/2017 T001759A 60049570 5/4/2017 T330V11A 60014160 3/29/2017 T333F00A 59987991 3/9/2017 T333F00A 60001468 3/16/2017 T333F00A 60022033 3/13/2017 T334041A 60008925 3/25/2017 T334041A 60049612 5/5/2017 T336547B 60008919 3/27/2017 T337305B 59987992 3/11/2017 T337305B 60001473 3/17/2017 T391314A 60020222 3/29/2017 T391T01A 60014163 3/30/2017 T395606B 60022034 3/13/2017 T395606B 60025971 4/14/2017 T430140A 60014177 3/31/2017 T430609A 60001486 3/16/2017 T430609A 60043616 4/27/2017 T431305A 60008942 3/25/2017 T431305A 60059909 5/8/2017 T440B20B 59994257 3/13/2017 T440B20B 60030953 4/17/2017 T440B21A 60025987 4/15/2017 T440B21A 59976182 3/11/2017 T440B26B 60030938 4/17/2017 T440B26B 60049616 5/4/2017 T443422A 60036750 4/29/2017 T443422A 60020223 4/15/2017 T449103B 60008929 3/24/2017 T449103B 60043599 4/28/2017 T450544A 60030944 4/20/2017 T494C00B 60020168 3/19/2017 T494C00B 60001415 3/25/2017 T494C00B 60043543 4/21/2017 T530116B 60022035 3/13/2017 T530116B 60008937 3/24/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2776-2015