83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Recall
- Recall Number
- Z-2621-2014
- Event Number
- 69088
- Firm
- ICU Medical, Inc.
- FEI Number
- 2025816
- Product Code
- FMG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 19, 2014
- Posted
- September 19, 2014
- Terminated
- November 18, 2014
- Address
- 951 Calle, Amanecer San Clemente, CA, 92673-6212
Description
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: [email protected]. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]. For questions regarding this recall call 801-264-1732.
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
100 units