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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91223

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

Open FDA event record

Event summary

Timeline bucket
November 23, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

3 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 3

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Z-0762-2023
Recall number
Z-0762-2023
Initiated
November 23, 2022
Classification
Class II
Status
Ongoing
Quantity
14,053,824 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Code information

UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.

device · product 2 of 3

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Z-0763-2023
Recall number
Z-0763-2023
Initiated
November 23, 2022
Classification
Class II
Status
Ongoing
Quantity
6,338,280 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Code information

a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.

device · product 3 of 3

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Z-0764-2023
Recall number
Z-0764-2023
Initiated
November 23, 2022
Classification
Class II
Status
Ongoing
Quantity
1,140,096 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Code information

No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.