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U.S. Department of Health and Human Services

Class 2 Device Recall OnQ Cbloc

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  Class 2 Device Recall OnQ Cbloc see related information
Date Initiated by Firm February 14, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-2133-2008
Recall Event ID 48454
510(K)Number K063530  
Product Classification Infusion Pump - Product Code MEB
Product On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.
Code Information Lot Numbers: 792457 and 7A2667
Recalling Firm/
Manufacturer		 I-Flow Corporation
20202 Windrow Dr
Lake Forest CA 92630-8152
For Additional Information Contact
949-206-2700
Manufacturer Reason
for Recall		 Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
FDA Determined
Cause 2		 Labeling design
Action Firm faxed customer notification letters to customers on February 14, 2008 advising that two lots of CB005 (lot numbers 792457 and 7A2667) may contain an incorrect fill port label. All other product labeling is correct for the CB005 pumps. Customers are asked to inspect the CB005 inventory to determine if they have any of the affected lots. If so, customers are not to use the product and quarantine any remaining inventory. Customers are also asked to provide a copy of the notification to end users who may have received CB005, lot numbers 792457 and 7A2667. A response form is also provided.
Quantity in Commerce 792457 (430 units) and 7A2667 (390 units)
Distribution Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.
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 = MEB and Original Applicant = I-FLOW CORP.
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