135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein

Class I - Dangerous

🏥 Medical Devices Recalled: July 6, 2020 ICU Medical Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Lot Number:4711366.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein