Date Initiated by Firm |
November 30, 2016 |
Date Posted |
January 10, 2017 |
Recall Status1 |
Terminated 3 on June 23, 2017 |
Recall Number |
Z-0980-2017 |
Recall Event ID |
75895 |
510(K)Number |
K964435
|
Product Classification |
Stopcock, i.V. Set - Product Code FMG
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Product |
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006
Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.
|
Code Information |
Lot No. 3323650 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
|
For Additional Information Contact |
949-366-2183
|
Manufacturer Reason for Recall |
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
An Urgent Medical Device Recall Notification letter dated 11/30/16 was sent to their customers to inform them that ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. The letter instructs the customers of the actions required and to return completed recall response form to ICU Medical via fax (801) 264-1755 or by email recall@icumed.com. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM and 4PM Pacific Time, (866) 829-9025 and select option 2 or email productreturns@icumed.com. |
Quantity in Commerce |
225 units |
Distribution |
US: NC |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FMG and Original Applicant = ICU MEDICAL, INC.
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