REVACLEAR recallZ-0760-2023 · Baxter Healthcare Corporation · initiated Nov 23, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA root cause category: Process change control
What the company is doing
Baxter Healthcare sent a notification via USPS first class mail on about 11/23/2022 and to home patients on about 11/29/2022. Consignees were instructed to locate and remove all affected product from your inventory, contact Baxter Healthcare Center for Service to arrange for return and credit, and acknowledge the receipt of the notification by completing a reply form on the customer portal. Note: this letter describes two issues. This recall addresses Internal Blood Leaks being caused by a twisted gasket in the dialyzer. The second issue is linked to reports of Polyurethane Displacement in the dialyzer, which is addressed in a separate recall.
Recall details
- Recall number
- Z-0760-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2022
- Posted by the FDA
- Dec 22, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 3,610,944 units
- Product code
- KDI
- FDA submissions
- K130039
- Distribution
- Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; 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, and Trinidad and Tobago.
Product description
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
UDI-DI: 07332414124076; Product Code: 114746L; Lot Numbers: C421222601, C421222701, C421222801, C421222901, C421223001, C421223101, C421223201, C421223301, C421223401, C421223501, C421223601, C421223701, C421223801, C421223901, C421224001, C421224101, C421224201, C421224301, C421224401, C421224601, C421224701, C421224801, C421224901, C421225001, C421225101, C421225201, C421225301, C421225401, C421225501, C421225601, C421225701, C421225801, C421225901, C421226001, C421226101, C421226201, C421226301, C421226401, C421226501, C421226601, C421226701, C421226801, C421226901, C421227001, C421227101, C421227201, C421227301, C421227401, C421227501, C421227601, C421227701, C421227801, C421227901, C421228001, C421228101, C421228201, C421228301, C421228401, C421228501, C421228601, C421228701, C421228801, C421228901, C421229001, C421229101, C421229201, C421229301, C421229401, C421231001, C421240001, C421240101, C421240201, C421240301, C421240401, C421240501, C421240601, C421240701, C421240801, C421240901, C421241001, C421241101, C421241201, C421241301, C421241401, C421241501, C421241601, C421241701, C421241801, C421241901, C421242001, C421242101, C421242201, C421242301, C421242401, C421242501, C421242601, C421242801, C422200101, C422200201, C422200301, C422200501, C422200601, C422200701, C422200801, C422200901, C422201001, C422201101, C422201201, C422201701, C422201801, C422202101, C422202201, C422202301, C422205001, C422205101, C422205201, C422205301, C422205701, C422205801, C422205901, C422206001, C422206101, C422206201, C422206301, C422206401, C422206501, C422206601, C422206701, C422206801, C422206901, C422207001, C422207201, C422207301, C422207401, C422207501, C422207601, C422207701, C422207801, C422207901, C422208001, C422208101, C422208201, C422208301, C422208401, C422208501, C422208601, C422208701, C422208801, C422208901, C422209001, C422209101, C422209201, C422209301, C422209401, C422209501, C422209801, C422209901, C422210001, C422210101, C422210201, C422210301, C422210401, C422210501, C422210601, C422210701, C422211201, C422211301, C422211401, C422211501, C422211601, C422211701, C422211801, C422211901, C422212001, C422212101, C422212201, C422212301, C422212401, C422212501, C422212601
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REVACLEAR 400Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls1 death44 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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