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

Hazard

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

Details from the source

Reason for recall: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer 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. Quantity: 3,610,944 units Lot/code info: 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,

UPC codes

07332414124076

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.