CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Neonatal PICC Tray, Product recalled by Vygon U

Vygon U is recalling Neonatal PICC Tray, Product, distributed nationwide in the US. The recall was initiated on 28 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 17C060D UDI: 08498840010563

Quantity recalled16520 total products

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-1634-2018
FDA event ID: 79752
Recalling firm: Vygon U, Lansdale, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2018
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

28 Feb 2018	Recall initiated by company
4 May 2018	Classified by FDA	+65 days
16 May 2018	Published in enforcement report	+12 days

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

Reason for recall

Potential friction holes may affect the sterility of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.

Where it was distributed

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Nationwide Arizona California Connecticut Florida Massachusetts Minnesota Missouri New Jersey Pennsylvania Texas Utah Virginia Wisconsin

Questions about this recall

Is Neonatal PICC Tray, Product recalled?

Yes. Vygon U recalled Neonatal PICC Tray, Product on 28 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1634-2018.

Why was it recalled?

Potential friction holes may affect the sterility of the product.

Which lots are affected?

Lot Number: 17C060D UDI: 08498840010563

Where was it sold?

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

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 Vygon U

All 11

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Vygon Dressing Change w/ Maxiswab recalled by Vygon U	Vygon U	Sterility	Nationwide
17 Apr 2019Device	CLASS II	Vyon Dualstop White Cap used for intravascular lines Product recalled	Vygon U	Packaging Defects	Nationwide
17 Apr 2019Device	CLASS II	Vygon Dualstop Red Cap used for intravascular lines Product recalled	Vygon U	Packaging Defects	Nationwide
16 May 2018Device	CLASS II	PICC Kit, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	PICC Insertion Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide

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