CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Gravity IV Set with 3-port Closed Stopcock Manifold recalled

Becton Dickinson & is recalling Gravity IV Set with 3-port Closed Stopcock Manifold, distributed in 10 states. The recall was initiated on 5 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes18105594 18105595 18105596 18105597

Quantity recalled21220 total cases of 20

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-1120-2019
FDA event ID: 82350
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2019
FDA classified: 10 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

5 Mar 2019	Recall initiated by company
10 Apr 2019	Classified by FDA	+36 days
17 Apr 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

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Product as listed by the FDA

Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07

Where it was distributed

Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.

Alabama California District of Columbia Florida Louisiana Maryland Nebraska Tennessee Virginia Washington

Questions about this recall

Is Gravity IV Set with 3-port Closed Stopcock Manifold recalled?

Yes. Becton Dickinson & recalled Gravity IV Set with 3-port Closed Stopcock Manifold on 5 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1120-2019.

Why was it recalled?

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Which lots are affected?

18105594 18105595 18105596 18105597

Where was it sold?

Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.

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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