FDAClass IIJune 25, 2014

NIPRO Safe Touch Safety Scalp Vein Set recall

NIPRO Safe Touch Safety Scalp Vein Set

Why was NIPRO Safe Touch Safety Scalp Vein Set recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
NIPRO Safe Touch Safety Scalp Vein Set
Recalling firm
Nipro Medical Corporation
Quantity
176,000 pieces
Distribution
Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
Recall date
June 25, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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