CARDINAL HEALTH 01A4553ERecalls & reported problems
Cardinal Health 200, LLC · IV START KIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 18, 2022Class IIOpen, Classified
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Z-1159-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other I.V. start kit devices
- Medline Industries, Inc. CDS860014PMedline Industries, Inc. · I.V. start kit3 recalls0 reports
- Medline Industries, Inc. DYKM1000BMedline Industries, Inc. · I.V. start kit3 recalls0 reports
- MEDLINE DYNJ68937AMedline Industries, Inc. · I.V. start kit2 recalls2 reports
- Centurion IVS3940BCenturion Medical Products Corporation · I.V. start kit2 recalls0 reports
- Centurion CVI3650Centurion Medical Products Corporation · I.V. start kit2 recalls0 reports
- MEDLINE DYNDV2465Medline Industries, Inc. · I.V. start kit2 recalls0 reports
- MEDLINE PICC0010Medline Industries, Inc. · I.V. start kit2 recalls0 reports
- Centurion IVS3900ACenturion Medical Products Corporation · I.V. start kit2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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