CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

APD Set with Cassette 3-Prong Peritoneal Dialysis Set recalled

Baxter Healthcare is recalling APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment. The recall was initiated on 16 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesH16F16088
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-1056-2017
FDA event ID
75998
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class II
Status
Terminated
Recall initiated
16 Dec 2016
FDA classified
19 Jan 2017
Reported
25 Jan 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

16 Dec 2016Recall initiated by company
19 Jan 2017Classified by FDA+34 days
25 Jan 2017Published 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

Customer complaints received for the presence of leaks

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

APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

Where it was distributed

US only

Questions about this recall

Is APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment recalled?

Yes. Baxter Healthcare recalled APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment on 16 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1056-2017.

Why was it recalled?

Customer complaints received for the presence of leaks

Which lots are affected?

H16F16088

Where was it sold?

US only

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.

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