FDAClass IIAugust 15, 2012

3mL 9NC Coagulation Sodium Citrate 3.2% recall

3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous…

Why was 3mL 9NC Coagulation Sodium Citrate 3.2% recalled?

Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

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 #B041206

Product
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous…
Recalling firm
Greiner Bio-One North America, Inc.
Quantity
838.9 cases (1,006,700 pieces)
Distribution
Nationwide Distribution
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls