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U.S. Department of Health and Human Services

Class 2 Device Recall DualCap Solo

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  Class 2 Device Recall DualCap Solo see related information
Date Initiated by Firm August 05, 2014
Date Posted September 05, 2014
Recall Status1 Terminated 3 on October 08, 2014
Recall Number Z-2595-2014
Recall Event ID 69066
510(K)Number K123065  
Product Classification Pad, alcohol, device disinfectant - Product Code LKB
Product DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile.

When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Code Information Lot 1406509
Recalling Firm/
Catheter Connections, Inc.
615 Arapeen Dr Ste 302A
Salt Lake City UT 84108
For Additional Information Contact Donald D. Solomon, PhD
Manufacturer Reason
for Recall
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
FDA Determined
Cause 2
Action The firm, Catheter Connections, sent an "Urgent: Medical Device Field Action" letter dated August 5, 2014 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to identify any customers who received this product having lot no. 1406509; make all potential users in your facility are made aware of this notification and the recommended actions; forward the attached URGENT MEDICAL DEVICE CORRECTION LETTER to customers immediately via fax or email; search your inventory and instruct all users to check each cap coming from the specific affected lot; quarantine and discard any defective product; and complete and return the attached URGENT MEDICAL DEVICE FIELD ACTION REPLY FORM via fax to 1-888-862-2693 or email to: info@cathconn.com. Catheter Connections does not require the return of devices having the affected lot number. If you have questions, please contact Catheter Connections at 1-801-906-0820 (M-F, 8:00 am - 5:00 pm MST) and ask for Quality Department.
Quantity in Commerce 24,910 units
Distribution US Distribution to states of: CT, GA, MD, and PA. .
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 = LKB and Original Applicant = CATHETER CONNECTIONS, INC.