Recall Z-2595-2014 ยท LKB Pad, Alcohol, Device Disinfectant
Catheter Connections, Inc.
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.
| Date | Sep 5, 2014 (initiated Aug 5, 2014) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 24,910 units |
| Distribution | US Distribution to states of: CT, GA, MD, and PA. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO Catheter Connections, Inc., Dec 14, 2012 |