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U.S. Department of Health and Human Services

Class 2 Device Recall Stopcock

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 Class 2 Device Recall Stopcocksee related information
Date Initiated by FirmApril 17, 2012
Date PostedAugust 02, 2012
Recall Status1 Terminated 3 on August 23, 2012
Recall NumberZ-2128-2012
Recall Event ID 62538
510(K)NumberK052865 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductHigh Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Code Information Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
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		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
ActionICU 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
Quantity in Commerce4625
DistributionNationwide distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQO
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