Recall Z-2621-2014— ICU Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by ICU Medical, Inc., initiated 2014-08-19, terminated 2014-11-18. It names one FDA 510(k) clearance: K964435. Product: 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.. Reason: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-08-19
- Terminated
- 2014-11-18
- Firm location
- San Clemente, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.