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Argyle

Cardinal Health, Inc. · Model 8888572578 · UDI-DI 10884521025486

GBS Prescription
10
510(k) clearances
32
Adverse events
20
Recalls
40
Facilities

Description

Silicone Thoracic Catheter Straight

Recalls

DateFirmReason
2010-08-10Atrium Medical CorporationMislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.
2010-08-10Atrium Medical CorporationMislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.
2009-02-27Concentric Medical IncProduct malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
2008-05-12Atrium Medical CorporationHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.