Baxter Healthcare Corporation Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Baxter Healthcare Corporation is recalling Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by h due to Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026