NIPRO Safe Touch Safety Scalp Vein Set

FDA device recall Z-1834-2014 · posted 2014-06-19 · Terminated

Recall details

Recalling firm

Nipro Medical Corporation

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.

Action taken

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

Status

Terminated

Product code

FOZ

Quantity affected

176,000 pieces

Distribution

Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.

Date initiated

2013-05-04

Date posted

2014-06-19

Date terminated

2015-03-02

Location

Miami, FL

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