Medical device recalls High risk

Nurse Assist, Inc recalls Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 120…

Recall date
October 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0926-2017
FDA classification
Class I
Brand / firm
Nurse Assist, Inc
Sold / distributed
Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

Why it was recalled

Potential contamination with B. cepacia.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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 usage: Saline flush

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