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N/A 4304CRecalls & reported problems

Carefusion 2200, Inc · Pediatric/Infant Lumbar Puncture Tray - 21 G x 2 1/2 Inch Spinal Needle with Manometer · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403057052), received between Jul 27, 2022 and Jul 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 20, 2022Open, Classified

    Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

    Z-0791-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED BY THE CUSTOMER THAT THE VIAL CONTAINS A FOREIGN OBJECT. VERBATIM: THE VIAL CONTAINS A FOREIGN OBJECT. APPEARS TO BE LINT OR A PIECE OF CARD BOARD. UN-OPEN RIGHT OUT OF THE TRAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15114318 ↗

Other Lumbar puncture tray (adult & pediatric) devices

All Lumbar puncture tray (adult & pediatric) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.