7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reported: February 17, 2021 Initiated: December 2, 2020 #Z-0957-2021
Product Description
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason for Recall
Due to the incorrect filter assembly.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- Total Kits = 7,500 for all four lots
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).. Recalled by ICU Medical, Inc.. Units affected: Total Kits = 7,500 for all four lots.
Why was this product recalled? ▼
Due to the incorrect filter assembly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-0957-2021.
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