FDAClass IISeptember 18, 2013

Monoject 0.9% Sodium Chloride Flush Syringe recall: Sterility Concern

Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush…

Why was Monoject 0.9% Sodium Chloride Flush Syringe recalled?

Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

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 Numbers: 13A0084N 13A0094 13B0364 13C0514

Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush…
Recalling firm
Covidien LLC
Quantity
3,235,860 units
Distribution
Worldwide Distribution - USA Nationwide and the country of Bermuda
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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