Manometer, Spinal-fluid
General Hospital · 21 CFR 880.2500
Recent MDR events
411 adverse event reports on file
- PEDIATRIC LUMBAR PUNCTURE TRAYApr 14, 2025MalfunctionBusse Hospital Disposables2433012-2025-00001
- BUSSE HOSPITAL DISPOSABLESNov 17, 2023MalfunctionRobert Busse Co., Inc.18159020
- BD SOLOMED¿ SYRINGE WITH NEEDLEFeb 11, 2019MalfunctionBecton Dickinson Ind. Cirurgicas Ltda3003916417-2019-00124
- HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICEJun 16, 2015MalfunctionSmiths Medical Md, Inc.2183502-2015-00418
- HYPODERMIC NEEDLE-PRO NEELDE WITH PROTECTION DEVICEJun 15, 2015MalfunctionSmiths Medical, Inc.2183502-2015-00417
- HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICEJun 12, 2015MalfunctionSmiths Medical, Inc.2183502-2015-00416
- HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICEJun 12, 2015MalfunctionSmiths Medical, Inc.2183502-2015-00409
- HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICEJun 8, 2015MalfunctionSmiths Medical Inc.2183502-2015-00404
- HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICEJun 8, 2015MalfunctionSmiths Medical Md, Inc.2183502-2015-00405
- HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICEJun 3, 2015MalfunctionSmiths Medical Inc2183502-2015-00393
Event type breakdown
Recalls
5 recall events for this product code
- Smiths Medical ASD, Inc.TerminatedNov 24, 2004
Portex Hypodermic Needle-Pro 5 ml Syringe,
Sterility of the device is compromised due to packaging defects
Z-0223-05 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedNov 24, 2004
Portex Hypodermic Needle-Pro 5 ml Syringe,
Sterility of the device is compromised due to packaging defects
Z-0224-05 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedNov 24, 2004
Hypodermic Needle-Pro 5 ml Syringe,
Sterility of the device is compromised due to packaging defects
Z-0225-05 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedNov 24, 2004
Portex Hypodermic Needle-Pro 5 ml Syringe,
Sterility of the device is compromised due to packaging defects
Z-0226-05 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
Lumbar Tray
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1150-2022 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Cardinal Health
Hazelwood, MO, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
B. Braun Medical Inc.
BETHLEHEM, PA, US
B. Braun Medical Inc.
Allentown, PA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Sterigenics U.s., Llc
Ontario, CA, US
B. Braun Us Device Manufacturing Llc
ALLENTOWN, PA, US
Sterigenics Us Llc
Los Angeles, CA, US
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
6 clearances for this product code
- PAJUNK GmbH MedizintechnologieJul 25, 2017
K170305 · Spinal Manometer NRFit; Spinal Manometer LUER
- Busse Hospital Disposables, Inc.Aug 28, 2003
K032432 · BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
- B.Braun Medical, Inc.Apr 7, 1997
K970287 · LUMBAR PUNCTURE KIT
- Smiths Industries Medical Systems, Inc.Oct 18, 1996
K963570 · SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
- Megadyne Medical Products, Inc.Jun 20, 1991
K910089 · MEGA LUMBAR PUNCTURE KIT
- Ansr Ent., Inc.Jun 29, 1988
K882405 · HYPODERMIC NEEDLE SHEATH HOLDER