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.
FDA Recall Z-2621-2014 · Posted 2014-09-19
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2014-08-19
Date Terminated2014-11-18
Product Quantity100 units
Reason for Recall
ICU is recalling the ConMed Stat 2 flow controller because it may
deliver a significantly higher flow rate than was intended.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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