FDAClass IIFebruary 4, 2015

Hepflush-10 recall

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC…

Why was Hepflush-10 recalled?

The lot failed pH specification.

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?

Lot 6005501, Exp. Date 1/2016

Product
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
Domestic: 69,725
Distribution
Nationwide Distribution
Recall date
February 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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