| Date Initiated by Firm | August 19, 2014 |
|---|
| Date Posted | September 19, 2014 |
|---|
| Recall Status1 |
Terminated 3 on November 18, 2014 |
| Recall Number | Z-2622-2014 |
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| Recall Event ID |
69088 |
| 510(K)Number | K964435 |
|---|
| Product Classification |
Stopcock, i.V. Set - Product Code FMG
|
| Product | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648.
Product Usage:
IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. |
|---|
| Code Information |
Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL |
Recalling Firm/
Manufacturer |
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
|
| For Additional Information Contact | Robert Reese
801-264-1732 |
|---|
Manufacturer Reason
for Recall | ICU is recalling the ConMed Stat 2 flow controller because it may
deliver a significantly higher flow rate than was intended. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| 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: 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. |
|---|
| Quantity in Commerce | 1150 units |
|---|
| Distribution | Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = FMG
|
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