| Class 2 Device Recall DualCap Solo |  |
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
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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/ Manufacturer |
Catheter Connections, Inc. 615 Arapeen Dr Ste 302A Salt Lake City UT 84108
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For Additional Information Contact | Donald D. Solomon, PhD 801-209-1269 |
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 | Packaging |
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.
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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 = LKB
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