NIPRO Safe Touch Safety Scalp Vein Set
FDA Recall Z-1834-2014 · Posted 2014-06-19
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Recalling FirmNipro Medical Corporation
Recall StatusTerminated
Product CodeFOZ
Date Initiated2013-05-04
Date Terminated2015-03-02
Product Quantity176,000 pieces
Reason for Recall
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.
Firm 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 in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621.
Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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