FDAJuly 9, 2021device
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Ap...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
What to do
FDA enforcement status: Terminated
Brands named
copan italiacopan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System2025-10-29
- FDA1ml of DTT in liquid phase, in PET tube with capture cap, in bulk2025-10-29
- FDAPhenoMATRIX2025-05-06
- FDABD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only2025-05-02
- FDACOPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.2023-07-14
- FDAPerceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval ...2020-07-29
- FDAPerceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implant...2020-07-29
- FDAPerceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval ...2020-07-29
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