Blood And Urine Collection Kit (excludes Hiv Testing)
Pathology · 21 CFR 864.3250
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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
7 adverse event reports on file
- MEDLINEJul 2, 2026MalfunctionTri-state De Mexico, S. De R.l. De C.v3004519921-2026-00033
- MEDLINEJul 2, 2026MalfunctionTri-state De Mexico, S. De R.l. De C.v3004519921-2026-00032
- MEDLINEApr 10, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00003
- BD VACUTAINER® URINE COLLECTION CUPFeb 29, 2024MalfunctionBecton, Dickinson And Company (bd)9617032-2024-00265
- BIOMERIEUX WORKSAFEDec 8, 2020MalfunctionBiomerieux, Inc.10966934
- AERO-MED URINE COLLECTION KITJun 19, 2018MalfunctionAero-med, Ltd.7613839
- *Aug 15, 2011Malfunction*2225753
Event type breakdown
Recalls
25 recall events for this product code
- Medline Industries, LPOpen, ClassifiedMay 7, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2119-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedApr 30, 2026
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Z-2040-2026 · View FDA record ↗ - LSL Healthcare Inc.Open, ClassifiedApr 22, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Z-1930-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 17, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1403-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 9, 2026
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Z-1333-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedJul 21, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Z-2155-2025 · 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-3059-2024 · 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-2754-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 27, 2024
Medline procedure packs containing Shenli syringes, labeled as follows:
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-2633-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1430-2024 · View FDA record ↗
Registered firms
45 firms currently registered for this product code
Idlife, Llc
Frisco, TX, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Ditek Consulting Llc
Glastonbury, CT, US
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Sirchie Acquisitions Company, Llc
YOUNGSVILLE, NC, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Saris And Things, Inc.
Plainfield, IL, US
Convertors De Mexico S. De R.l. De C.v
Ciudad Juarez Chihuahua, MX
Cardinal Health
DELAND, FL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Revvity Health Sciences, Inc.
Greenville, SC, US
Aero-med Llc
East Hartford, CT, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Sterigenics U.s., Llc
Ontario, CA, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Spot Health Inc.
Cincinnati, OH, US
Home Access Health Corp.
Hoffman Est, IL, US
Cardinal Health 200, Llc
Waukegan, IL, US
Ixlayer
San Francisco, CA, US
Isomedix Operations Inc
EL PASO, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.