Z-1834-2014Class II

NIPRO Safe Touch Safety Scalp Vein Set

Name: Z-1834-2014 NIPRO Safe Touch Safety Scalp Vein Set
Creator: Nipro Medical Corporation
Published: 2013-05-04
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2013-05-04 / Terminated / root cause: design

FDA source

Nipro Medical Corporation began a recall of NIPRO Safe Touch Safety Scalp Vein Set on 2013-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1834-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-04
Posted: 2014-06-19
Terminated: 2015-03-02
Recalling firm: Nipro Medical Corporation
Product: NIPRO Safe Touch Safety Scalp Vein Set
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 176,000 pieces
Distribution: Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
Product codes and lots: Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-19

Product code FOZ

K011297Class IINipro Safetouch Scalp Vein and Blood Collection SetNipro Medical Corp. / cleared 2001-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)