CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report

BD Posiflush Pre-Filled Normal Saline Syringes recalled

Becton Dickinson & is recalling BD Posiflush Pre-Filled Normal Saline Syringes, distributed nationwide in the US. The recall was initiated on 14 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 9175971 UDI: 50382903065757

Quantity recalled967,680

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-0500-2020
FDA event ID: 84113
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2019
FDA classified: 20 Nov 2019
Reported: 27 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

14 Oct 2019	Recall initiated by company
20 Nov 2019	Classified by FDA	+37 days
27 Nov 2019	Published in enforcement report	+7 days

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

Reason for recall

Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

Product as listed by the FDA

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Where it was distributed

Distribution US Nationwide and Canada

Nationwide

Questions about this recall

Is BD Posiflush Pre-Filled Normal Saline Syringes recalled?

Yes. Becton Dickinson & recalled BD Posiflush Pre-Filled Normal Saline Syringes on 14 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0500-2020.

Why was it recalled?

Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

Which lots are affected?

Lot Number: 9175971 UDI: 50382903065757

Where was it sold?

Distribution US Nationwide and 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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 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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