Z-2595-2014 Class II Terminated
FDA device recall Z-2595-2014 was initiated by Catheter Connections, Inc. on August 5, 2014 and is designated Class II. 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. The recall status is terminated (terminated October 8, 2014). Affected quantity: 24,910 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2014
- Initiation Date
- August 5, 2014
- Termination Date
- October 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,910 units
Product Description
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.
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.
Distribution Pattern
US Distribution to states of: CT, GA, MD, and PA. .
Code Information
Lot 1406509