CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report

Kit, Port Access Product recalled by Centurion Medical Products

Centurion Medical Products is recalling Kit, Port Access, distributed in Illinois. The recall was initiated on 15 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number Expiration 2018121350 8/31/2020 2019020750 9/30/2020 2019031550 4/30/2021 2019041550 4/30/2021 2019061750 1/31/2021 2019062450 4/30/2021

Quantity recalled11260 kits

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-0255-2020
FDA event ID: 83542
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 15 Jul 2019
FDA classified: 31 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Jul 2019	Recall initiated by company
31 Oct 2019	Classified by FDA	+108 days
6 Nov 2019	Published in enforcement report	+6 days

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

Reason for recall

Supplier initiated recall of the GRIPPER Needles

Product as listed by the FDA

Kit, Port Access Product Code: DYNDC1582A

Where it was distributed

Illinois

Questions about this recall

Why was it recalled?

Supplier initiated recall of the GRIPPER Needles

Which lots are affected?

Lot Number Expiration 2018121350 8/31/2020 2019020750 9/30/2020 2019031550 4/30/2021 2019041550 4/30/2021 2019061750 1/31/2021 2019062450 4/30/2021

Where was it sold?

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 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.

Other products in this recall event

3 other products · FDA event 83542

This product is part of a recall event; the main page for the event is Port Access Infusion Kit - 1" Needle Product recalled.

Reported	Class	Recall	Company	Reason	Where
6 Nov 2019	CLASS II	Port Access Infusion Kit - 1" Needle Product recalled	Centurion Medical Products	Other	IL
6 Nov 2019	CLASS II	Maintenance Flush Kit/Blood Draw Product recalled	Centurion Medical Products	Other	IL
6 Nov 2019	CLASS II	Port full Access Tray Product recalled by Centurion Medical Products	Centurion Medical Products	Other	IL

More recalls from Centurion Medical Products

All 152

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020Device	CLASS II	Centurion Difficult IV KIT containing BD's Vacutainer recalled	Centurion Medical Products	Foreign Material	Nationwide
12 Feb 2020Device	CLASS II	Centurion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalled	Centurion Medical Products	Sterility	Nationwide

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