Container, Specimen, Non-sterile
Pathology · 21 CFR 864.3250
Recent MDR events
28 adverse event reports on file
- CONTAINER, SPECIMEN, NON-STERILESep 13, 2024Malfunction20211180
- DEROYALJul 5, 2022MalfunctionDeroyal3014527682-2022-00010
- THORA-PARA NON-VALVED (OTP) CATHETER DRAINAGE SYSTEMFeb 11, 2022InjuryCarefusion, Inc1625685-2022-00028
- THORA-PARA VALVED (TPT)Jan 13, 2022InjuryCarefusion, Inc1625685-2022-00008
- SPECIMEN CONTAINEROct 4, 2021MalfunctionRichard Allen Lla - Subsidiary Of Epradia12567859
- CONTAINER, SPECIMEN, NON-STERILEJul 14, 2021MalfunctionCardinal Health 200, Llc12165784
- 10% NEUTRAL BUFFERED FORMALIN CONTAINERMay 26, 2021MalfunctionSlmp Llc (statlab Medical Products)11884726
- BD COR PX BIO WASTE BAG (PACK OF 50)Mar 2, 2021MalfunctionBecton, Dickinson & Co. (sparks)1119779-2021-00413
- CONTAINER, SPECIMEN, NON-STERILEOct 8, 2020MalfunctionMedegen Medical Products10648073
- SIMPORT SCIENTIFICJul 14, 2020MalfunctionCardinal Health10270196
Event type breakdown
Recalls
4 recall events for this product code
- Milestone S.R.L.Open, ClassifiedApr 24, 2026
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
There is a possibility of reagent leakage from the specimen container.
Z-1944-2026 · View FDA record ↗ - Cardinal Health IncTerminatedMar 30, 2011
Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in
In one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)
Z-1852-2011 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldTerminatedUnknown
Michels Transport Medium, 20ML Prefilled Cont
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Z-0656-2022 · View FDA record ↗ - Dynarex CorporationTerminatedUnknown
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Z-2057-2016 · View FDA record ↗
Registered firms
336 firms currently registered for this product code
Guenter Bissinger Medizintechnik Gmbh
TENINGEN Baden-Wurttemberg, DE
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Klinika Medical Gmbh
Usingen Hesse, DE
Joykey Industrial (pinghu) Limited
Pinghu City Zhejiang, CN
Premium Plus International Limited
Hong Kong, HK
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Pac-dent Inc.
Brea, CA, US
Medical Transportation Devices Limited
Aylesford Kent, GB
Fridababy Llc
Miami, FL, US
Jiangsu Jianyu Health Medical Co., Ltd
Changzhou City Jiangsu, CN
Quintron Instrument Co. Inc.
New Berlin, WI, US
Guangzhou Improve Medical Instruments Co., Ltd.
Guangzhou Guangdong, CN
Tf New Material Sci And Tec Co.,ltd
Huainan Anhui, CN
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Ningbo Tianbo First Aid Product Co., Ltd.
Ningbo Zhejiang, CN
Sysmex America, Inc.
Lincolnshire, IL, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Labotek Group Corp
Bayamon, PR, US
Wondfo Usa Co., Ltd.
Bolingbrook, IL, US
Beekley Corporation
Bristol, CT, US
Advanced Instruments, Llc
NORWOOD, MA, US
Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
Diagnostics For The Real World, Ltd.
Morgan Hill, CA, US
F.l. Medical S.r.l. Unipersonale
Torreglia Padova, IT
Ningbo Castle Medical Import & Export Co.,ltd
Ningbo Zhejiang, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.