REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)

Class I - Dangerous

🏥 Medical Devices Recalled: March 16, 2021 ICU Medical Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
REF: 20130-01 UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5135750 (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5142982 Lot Number: 5135750 5142982
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:: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)

Product Codes/Lot Numbers:

REF: 20130-01 UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5135750 (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5142982 Lot Number: 5135750 5142982