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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90032

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

15 Liters Drain Bag

Z-1141-2022
Recall number
Z-1141-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
510 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product code: R5C4145P; UDI: 05413760005386; Lot Numbers: H17H14104 (exp. date: 07/31/2022), H20K02117 (exp. date: 11/02/2025), H21H24081 (exp. date: 08/24/2026)

Distribution pattern

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

device · product 2 of 6

Locking Cap for PD Catheter Adapter

Z-1142-2022
Recall number
Z-1142-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product code: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)

Distribution pattern

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

device · product 3 of 6

5 Prong Manifold Set (with Luer Connectors)

Z-1143-2022
Recall number
Z-1143-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product code: R5C4427; UDI: 00085412008691; Lot Number: H17D26065 (exp. date: 04/26/2022), Lot Number: H17I18046 (exp. date: 09/18/2022), Lot Number: H18C20051 (exp. date:03/20/2023), Lot Number: H19J24041 (exp. date:10/24/2024)

Distribution pattern

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

device · product 4 of 6

Effluent Sample Bag

Z-1144-2022
Recall number
Z-1144-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
78 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

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

device · product 5 of 6

3,65 m Extension Set with Luer-lock Connector

Z-1145-2022
Recall number
Z-1145-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)

Distribution pattern

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

device · product 6 of 6

APD Drain Manifold

Z-1146-2022
Recall number
Z-1146-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product code: R5C4512; UDI: 00085412008790; Lot Number: H18D03030 (exp. date: 04/03/2023), Lot Number: H18E31046 (exp. date: 05/31/2023), Lot Number: H18L04065 (exp. date:12/04/2023), Lot Number: H20H10073 (exp. date: 08/10/2022)

Distribution pattern

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