FDANovember 15, 2019device
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
What to do
FDA enforcement status: Terminated
Brands named
baxter healthcarebaxter
UPCs
07332414123055
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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