STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer,
FDA device recall Z-2620-2014 · posted 2014-09-19 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
- Action taken
- 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: recall@icumed.com. 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: customerservice@icumed.com. For questions regarding this recall call 801-264-1732.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 1250 units
- Distribution
- Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
- Date initiated
- 2014-08-19
- Date posted
- 2014-09-19
- Date terminated
- 2014-11-18
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMARY IV SET (K964435) | Icu Medical, Inc. | 1997-04-02 |