CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

Hct Max Barrier Picc Insertion Tray recalled by Stradis Healthcare

Stradis Healthcare is recalling Hct Max Barrier Picc Insertion Tray, distributed nationwide in the US. The recall was initiated on 15 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAssembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373

Quantity recalled200 units

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-0941-2023
FDA event ID: 91350
Recalling firm: Stradis Healthcare, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 15 Dec 2022
FDA classified: 11 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

15 Dec 2022	Recall initiated by company
11 Jan 2023	Classified by FDA	+27 days
18 Jan 2023	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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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

HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Where it was distributed

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Nationwide Florida Illinois Indiana Massachusetts Mississippi Nevada Ohio Tennessee Texas Washington

Questions about this recall

Is Hct Max Barrier Picc Insertion Tray recalled?

Yes. Stradis Healthcare recalled Hct Max Barrier Picc Insertion Tray on 15 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0941-2023.

Why was it recalled?

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Which lots are affected?

Assembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373

Where was it sold?

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

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 Stradis Healthcare

All 71

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Hct Central Line Insertion Tray, I recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	HCT, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack recalled	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Tacy Medical, Inc Port Access Tray, Sterile, Qty recalled	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Picc Kit, 10/cs, Access Medical Label recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Henry Shein Cysto Set UP Pack recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide

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