Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-0760-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Product Classification:

Class II

Date Initiated: November 23, 2022

Date Posted: December 28, 2022

Recall Number: Z-0760-2023

Event ID: 91222

Reason for Recall:

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

Status: Ongoing

Product Quantity: 3,610,944 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated