CARDINAL HEALTH 01-96001ARecalls & reported problems
Cardinal Health 200, LLC · IV START W 1683 AND 1ML R · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488494029), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Sharp Edges1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Detachment of Device or Device Component; Sharp Edges
PATIENT TO RECEIVE CONTRAST FOR HIS MRI EXAM. WAS STARTING HIS IV, USED THE APPLICATOR PREP PROVIDED IN IV START KIT. THE SPONGE HEAD OF PREP APPLICATOR CAME OFF WHILE PREPPING THE IV SITE. SMALL SHARDS OF GLASS FROM THE APPLICATOR NICKED PATIENTS SKIN.
Patient problems: Needle Stick/Puncture
MAUDE report 12452567 ↗
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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