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Recall Observatory FDA recall evidence

Device product

NIPRO Safe Touch Safety Scalp Vein Set

Z-1834-2014

May 04, 2013

Class II

Product summary

Firm
Nipro Medical Corporation
Event
Event 65274
Status
Terminated
Classification
Class II
Quantity
176,000 pieces
Official record key
device-enforcement:Z-1834-2014

Official wording

Reason: 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.

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.