Recall Z-1834-2014 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Nipro Medical Corporation
NIPRO Safe Touch Safety Scalp Vein Set
| Date | Jun 19, 2014 (initiated May 4, 2013) |
| Status | Terminated |
| Reason | There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids. |
| Root cause | Component design/selection |
| Action | Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have |
| Quantity | 176,000 pieces |
| Distribution | Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET Nipro Medical Corp., Jun 20, 2001 |