STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Reported: October 1, 2014 Initiated: August 19, 2014 #Z-2620-2014
Product Description
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. 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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 1250 units
- Distribution
- Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.. Recalled by ICU Medical, Inc.. Units affected: 1250 units.
Why was this product recalled? ▼
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2014. Severity: Critical. Recall number: Z-2620-2014.
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