CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report

Cvc Bundle Without Cath Cvi4600 recalled by Centurion Medical Products

Centurion Medical Products is recalling Cvc Bundle Without Cath Cvi4600, distributed nationwide in the US. The recall was initiated on 24 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2019022550 2019032250

Quantity recalled181965 total

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-0079-2020
FDA event ID: 83584
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2019
FDA classified: 9 Oct 2019
Reported: 16 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Apr 2019	Recall initiated by company
9 Oct 2019	Classified by FDA	+168 days
16 Oct 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

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CVC BUNDLE WITHOUT CATH CVI4600

Where it was distributed

Nationwide domestic distribution.

Nationwide

Questions about this recall

Is Cvc Bundle Without Cath Cvi4600 recalled?

Yes. Centurion Medical Products recalled Cvc Bundle Without Cath Cvi4600 on 24 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-0079-2020.

Why was it recalled?

Which lots are affected?

2019022550 2019032250

Where was it sold?

Nationwide domestic distribution.

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.

More recalls from Centurion Medical Products

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