CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile recalled

Baxter Healthcare is recalling L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path, distributed in 13 states. The recall was initiated on 10 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number H18D22030

Quantity recalled8640 eaches

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-0030-2020
FDA event ID: 83191
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2018
FDA classified: 3 Oct 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Oct 2018	Recall initiated by company
3 Oct 2019	Classified by FDA	+358 days
9 Oct 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

Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.

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

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

Where it was distributed

U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.

California District of Columbia Delaware Florida Georgia Maryland North Carolina Nevada Pennsylvania South Carolina Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number H18D22030

Where was it sold?

U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) 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.

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