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

Triple Lumen Cvc Bundle Stcvc2040 recalled by Centurion Medical Products

Centurion Medical Products is recalling Triple Lumen Cvc Bundle Stcvc2040, 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 codes2018110150 2018120350 2018121050 2019021150 2019021550

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-0106-2020
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

TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040

Where it was distributed

Nationwide domestic distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

2018110150 2018120350 2018121050 2019021150 2019021550

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 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

32 other products · FDA event 83584

This product is part of a recall event; the main page for the event is Pediatric Picc Insertion Tray Cvi4450a recalled.

Reported	Class	Recall	Company	Reason	Where
16 Oct 2019	CLASS II	Pediatric Picc Insertion Tray Cvi4450a recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Or Vantex Cvc Ecvc6665 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	PICC Line Accessory Kit CVI4285 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Neonatal Procedure Tray Picc Catheters Cvi4535 recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Neonatal Cap Change Kit DT20315 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle, Pi Ecvc5120 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cap Change Kit DT20310 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle Multimed Ecvc6060 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Insertion Bundle recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle Without Cath Cvi4600 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Triple Lumen Safety Bundle Ecvc6070 recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle Vantex 7f Ecvc6065 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle, Pi Ecvc5095 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Invasive Procedure Tray Mns9510 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Central Line Bundle Multimed Ecvc6545a recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cvc Bundle, Pi Ecvc5120a recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Infusa Port Kit Dyndc1840e recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Central Line Bundle Multimed Ecvc6545 recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Iv Securement Kit Ivs3405 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cap Change Kit Dyndc1496b recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Sterile Cap Change Kit Dyndc1946b recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Triple Lumen Bundle Kit Ecvc1540 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Infusa Port Kit Dyndc1840f recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Uvc Tray Uvt875 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Iv Start Kit Iv8440 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Vantex Cvc Bundle Ecvc6670 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Port And Io Access Dressing Kit Dt15780a recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Central Line Bundle Ecvc6375 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Iv Kit - Sorbaview Ivs3475 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Cap Bundle Kit Dyndc2137 recalled by Centurion Medical Products	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Pediatric Picc Insertion Tray Cvi4450 recalled	Centurion Medical Products	Packaging Defects	Nationwide
16 Oct 2019	CLASS II	Central Venous Access Device Bundle Ecvc2840 recalled	Centurion Medical Products	Packaging Defects	Nationwide

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

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
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16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide