CLASS I Device recall · Reported 11 Jan 2017 · FDA Enforcement Report

Normal Saline Flush 0.9% USP Sodium Chloride Injection recalled

Nurse Assist is recalling Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe fill and fill, distributed nationwide in the US. The recall was initiated on 4 Oct 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesItem 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)

Quantity recalled386,175 syringes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0926-2017
FDA event ID: 75348
Recalling firm: Nurse Assist, Haltom City, TX
Classification: Class I
Status: Terminated
Recall initiated: 4 Oct 2016
FDA classified: 3 Jan 2017
Reported: 11 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

4 Oct 2016	Recall initiated by company
3 Jan 2017	Classified by FDA	+91 days
11 Jan 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential contamination with B. cepacia.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

Nationwide

Questions about this recall

Why was it recalled?

Potential contamination with B. cepacia.

Which lots 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)

Where was it sold?

Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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