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.
FDA Recall Z-2595-2014 · Posted 2014-09-05
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Recalling FirmCatheter Connections, Inc.
Recall StatusTerminated
Product CodeLKB
Date Initiated2014-08-05
Date Terminated2014-10-08
Product Quantity24,910 units
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.
Firm 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: [email protected].
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.
Root Cause
Packaging
Distribution Pattern
US Distribution to states of: CT, GA, MD, and PA. .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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