CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

Pediatric Iv & Iv Start Kit recalled by Centurion Medical Products

Centurion Medical Products is recalling Pediatric Iv & Iv Start Kit, distributed nationwide in the US. The recall was initiated on 23 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIV5785 IV6135 Lot codes: 2015121890 2016031490 2016102490 2016111490 2017012390 2017050890 2016071190 2015101990 2015120790 2016010490 2016012590 2016101090 2017010290 2017061990 2017071090

Quantity recalledN/A

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-1092-2018
FDA event ID: 79329
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2017
FDA classified: 17 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Oct 2017	Recall initiated by company
17 Mar 2018	Classified by FDA	+145 days
28 Mar 2018	Published in enforcement report	+11 days

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

Reason for recall

Convenience Kit containing components to assist practitioner with IV placement and securement.

Product as listed by the FDA

PEDIATRIC IV & IV START KIT

Where it was distributed

Nationally

Nationwide

Questions about this recall

Why was it recalled?

Convenience Kit containing components to assist practitioner with IV placement and securement.

Which lots are affected?

IV5785 IV6135 Lot codes: 2015121890 2016031490 2016102490 2016111490 2017012390 2017050890 2016071190 2015101990 2015120790 2016010490 2016012590 2016101090 2017010290 2017061990 2017071090

Where was it sold?

Nationally

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

20 other products · FDA event 79329

This product is part of a recall event; the main page for the event is Neonatal Iv Access Set recalled by Centurion Medical Products.

Reported	Class	Recall	Company	Reason	Where
28 Mar 2018	CLASS II	Neonatal Iv Access Set recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	General Purpose Instrument Tray recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Suture Removal Tray, Set or Kit recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Latex Free Iv Start Set recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Catheter Securement System recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Neonatal Iv Start Kit recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	IV Start KIT recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Infant Iv Securement Kit recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Mini Plastics Set recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	SorbaView Shield Dressing Change Tray recalled	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Blood Draw Kit recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Minor Dressing Change Tray recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Excision Tray recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Wound Care Kit recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Incision & Drainage Tray or Kit recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Tubing Change Kit recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Wound Closure Tray - Facial recalled by Centurion Medical Products	Centurion Medical Products	Other	Nationwide
28 Mar 2018	CLASS II	Skin Staple Remover recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	St. Christopher's Securement Set recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	Nationwide
28 Mar 2018	CLASS II	Circumcision Tray recalled by Centurion Medical Products	Centurion Medical Products	Potency & Assay	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
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
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