Z-2595-2014Class II

DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for...

Name: Z-2595-2014 DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for...
Creator: Catheter Connections, Inc.
Published: 2014-08-05
License: https://open.fda.gov/license/

Catheter Connections, Inc. / initiated 2014-08-05 / Terminated / root cause: packaging

FDA source

Catheter Connections, Inc. began a recall of 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... on 2014-08-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2595-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-05
Posted: 2014-09-05
Terminated: 2014-10-08
Recalling firm: Catheter Connections, Inc.
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.
Product code: LKB Pad, Alcohol, Device Disinfectant
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.
Root cause tag: packaging
FDA root cause: 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: [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.
Quantity in commerce: 24,910 units
Distribution: US Distribution to states of: CT, GA, MD, and PA. .
Product codes and lots: Lot 1406509

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2595-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2595-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-05

Product code LKB

K123065Class IICatheter Connections Dualcap SoloCatheter Connections, Inc. / cleared 2012-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)