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U.S. Department of Health and Human Services

Class 2 Device Recall Flush Kit

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  Class 2 Device Recall Flush Kit see related information
Date Initiated by Firm April 17, 2012
Date Posted August 02, 2012
Recall Status1 Terminated 3 on August 23, 2012
Recall Number Z-2131-2012
Recall Event ID 62538
510(K)Number K052865  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Flush Kit w 3 Way Off Stopcock

Product Usage:
Flush Kit
Code Information Part Number AG8137 510(k) K052865 Lot number 2466161
Recalling Firm/
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
Manufacturer Reason
for Recall
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
FDA Determined
Cause 2
Nonconforming Material/Component
Action ICU Medical sent an Urgent Medical Device Recall letter dated April 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to inspect inventory, destroy affected products according to hospital protocol, complete and return verification form and contact ICU Customer Service to order replacement products. The letter states that ICU Medical will credit customer for any product destroyed once the completed verification form is received. This recall should be carried out to the user level and passed on to all those who need to be aware within your organization or any other organization the device may have been transferred to. Should you have any questions or require assistance relating to this recall please 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
Distribution Nationwide distribution
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 = DQO and Original Applicant = ICU MEDICAL, INC.