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Covidien

Cardinal Health, Inc. · Model 8881389459 · UDI-DI 10884521174009

GIM
10
510(k) clearances
1,965
Adverse events
9
Recalls
36
Facilities

Description

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Recalls

DateFirmReason
2025-08-08Greiner Bio-One North America, Inc.Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample re
2021-08-20Greiner Bio-One North America, Inc.Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
2021-03-29Greiner Bio-One North America, Inc.VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activ
2020-03-12Greiner Bio-One North America, Inc.Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
2017-02-23StreckComplaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to p
2012-07-02Greiner Bio-One North America, Inc.Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
2012-03-05bioMerieux, Inc.The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collecti
2006-08-02Greiner Bio-One North America, Inc.Coagulation tubes found with no additive.
2004-07-27Greiner VACUETTE North AmericaCoagulation tubes may not have received the proper fill of citrate solution.

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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.