Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 1, 2014
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. 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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Icu Medical, Inc. recalled STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2… - a critical-severity action.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2… was recalled by Icu Medical, Inc. in October 1, 2014. Reason: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate …. Check the official notice for the remedy. Verify recall #Z-2619-2014 with the FDA Devices before acting.
The recall
Icu Medical, Inc. issued this critical-severity FDA Devices recall-ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate ….
- Critical
- severity level
- 4K units
- affected scope
- Class I
- classification
- October 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2619-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2619-2014) was formally reported on October 1, 2014, with the manufacturer initiating the action on August 19, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Icu Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records list the affected scope as 3750 units.
The documented reason for this recall is: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3750 units
Related Recalls
6
3 from same agency
Product description
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2619-2014 |
| Date reported | October 1, 2014 |
| Date initiated | August 19, 2014 |
| Recalling firm | Icu Medical, Inc. |
| Firm location | San Clemente, CA |
| Affected scope | 3750 units |
| Distribution | Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2619-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. 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: 3750 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-2619-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2619-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 1, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.