Lumbar Puncture Tray (adult & Pediatric)
General Hospital · 21 CFR 880.5570
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
57 adverse event reports on file
- LUMBAR PUNCTURE TRAYMar 30, 2026MalfunctionMedline/centurion Medical Products, LpMW5186054
- LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DPDec 3, 2024InjuryCarefusion, Inc1625685-2024-00134
- N/ANov 12, 2024MalfunctionCarefusion 2200, Inc20662047
- PH ADT LUM PUNCT TRAY 22 X 3 1/2Oct 23, 2024MalfunctionMedline Industries Lp1417592-2024-00913
- MEDLINE LUMBAR PUNCTURE TRAY 20G3.5May 13, 2024MalfunctionMedline Industries, Inc.19297399
- LUMBAR PUNCTURE TRAYMar 29, 2024MalfunctionMedline Industries, Inc.19002909
- LUMBAR PUNCTURE TRAY ADULTNov 10, 2023InjuryCarefusion, Inc1625685-2023-00108
- SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTNov 10, 2023MalfunctionCarefusion, Inc1625685-2023-00109
- SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTNov 10, 2023MalfunctionCarefusion, Inc1625685-2023-00110
- SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTNov 10, 2023MalfunctionCarefusion, Inc1625685-2023-00111
Event type breakdown
Recalls
21 recall events for this product code
- Medline Industries, LPOpen, ClassifiedJun 29, 2026
Medline Convenience Kits:
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Z-2544-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3041-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 28, 2024
Medline procedural kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2758-2024 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0540-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0541-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Safety-Deluxe Lumbar Puncture Tray, Catalog # 975
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0542-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0543-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Laceration Tray, Catalog # 1892R1
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0544-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Lumbar Puncture Tray, Catalog # 1862
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0545-2018 · View FDA record ↗ - Robert Busse & Co. Inc. d.b.a. Busse Hospital DisposablesTerminatedUnknown
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Z-0546-2018 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
Carefusion 2200, Inc.
Vernon Hills, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Atlanta, GA, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Centurion Medical Products, Lp
HOWELL, MI, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Isomedix Operations Inc
EL PASO, TX, US
Isomedix Operations Inc
El Paso, TX, US
Cardinal Health
Hazelwood, MO, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Sterling Medical Products
Prophetstown, IL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
El Paso, TX, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.