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Recall Observatory FDA recall evidence

Device 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.

Z-2595-2014

August 05, 2014

Class II

Product summary

Firm
Catheter Connections, Inc.
Event
Event 69066
Status
Terminated
Classification
Class II
Quantity
24,910 units
Official record key
device-enforcement:Z-2595-2014

Official wording

Reason: 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.

Code information: Lot 1406509

Distribution pattern: US Distribution to states of: CT, GA, MD, and PA. .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.