FDAFDA · Food and drugs·Recall number Z-1834-2014
NIPRO Safe Touch Safety Scalp Vein Set
Published June 25, 2014 · Recall initiated: May 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nipro Medical Corporation
- Distributor
- Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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