CLASS II Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

Effluent Sample recalled by Baxter Healthcare

Baxter Healthcare is recalling Effluent Sample, distributed nationwide in the US. The recall was initiated on 21 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct code: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)

Quantity recalled78 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-1144-2022
FDA event ID: 90032
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 21 Apr 2022
FDA classified: 27 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Apr 2022	Recall initiated by company
27 May 2022	Classified by FDA	+36 days
8 Jun 2022	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

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Product as listed by the FDA

Effluent Sample Bag

Where it was distributed

US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

Nationwide Arizona California Florida Massachusetts Maryland Missouri New York Ohio Texas

Questions about this recall

Is Effluent Sample recalled?

Yes. Baxter Healthcare recalled Effluent Sample on 21 Apr 2022. The recall is Class II and its status is Terminated. Recall number Z-1144-2022.

Why was it recalled?

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Which lots are affected?

Product code: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)

Where was it sold?

US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

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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