Z-1834-2014 Class II Terminated
FDA device recall Z-1834-2014 was initiated by Nipro Medical Corporation on May 4, 2013 and is designated Class II. 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 … The recall status is terminated (terminated March 2, 2015). Affected quantity: 176,000 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- May 4, 2013
- Termination Date
- March 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176,000 pieces
Product Description
NIPRO Safe Touch Safety Scalp Vein Set
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.
Distribution Pattern
Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
Code Information
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.