FDAClass IJanuary 11, 2017

Normal Saline Flush 0.9% USP Sodium Chloride Injection recall: Contamination

Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product…

Why was Normal Saline Flush 0.9% USP Sodium Chloride Injection recalled?

Potential contamination with B. cepacia.

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?

Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)

Product
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product…
Recalling firm
Nurse Assist, Inc
Quantity
386,175 syringes
Distribution
Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
Recall date
January 11, 2017
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls