Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure b...
FDA Recall #Z-0760-2023 — Class II — November 23, 2022
Product Description
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Reason for Recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,610,944 units
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.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.