Thoracentesis Tray
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
162 adverse event reports on file
- SAFE-T-CENTESIS TRAY 6FR X 16CMJul 27, 2026MalfunctionCarefusion, Inc1423507-2026-00112
- SAFE-T-CENTESISJul 21, 2026MalfunctionCarefusion, Inc1423507-2026-00110
- SAFE-T-CENTESIS KIT 8FR X 16CMJul 21, 2026MalfunctionCarefusion, Inc1423507-2026-00109
- SAFE-T-CENTESIS KIT 8FR X 16CMJul 21, 2026MalfunctionCarefusion, Inc1423507-2026-00108
- THORA/PARA TRAY, 5FR, NON-VALVEDJul 2, 2026MalfunctionCarefusion, Inc1423507-2026-00098
- Safe-T-CentesisJun 30, 2026MalfunctionCarefusion, Inc1423507-2026-00096
- SAFE-T-CENTESIS TRAY 6FR X 16CMJun 29, 2026MalfunctionCarefusion, Inc1423507-2026-00094
- THORA/PARA TRAY, 5FR, NON-VALVEDJun 19, 2026MalfunctionCarefusion, Inc1423507-2026-00090
- SAFE-T-CENTESISJun 10, 2026MalfunctionCarefusion, Inc1423507-2026-00082
- SAFE-T-CENTESIS DRAINAGE SYSTEMJun 8, 2026MalfunctionCarefusion 2200, Inc25427559
Event type breakdown
Recalls
19 recall events for this product code
- Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2655-2026 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
CK000495A Poly Midline Catheter 4 Fr Single-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2656-2026 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2657-2026 · View FDA record ↗ - Bard Peripheral Vascular IncOpen, ClassifiedDec 5, 2025
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Z-0887-2026 · View FDA record ↗ - Bard Peripheral Vascular IncOpen, ClassifiedUnknown
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Z-1273-2022 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2646-2020 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2647-2020 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Safe-T-Centesis 6 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2648-2020 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2649-2020 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2650-2020 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
C.r. Bard, Inc.
MADISON, GA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
El Paso, TX, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Carefusion 2200, Inc.
Vernon Hills, IL, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Merit Medical Uk Limited
Earley Reading, GB
Merit Medical Systems, Inc
Chester, VA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Carefusion 2200, Inc.
Mannford, OK, US
Sterigenics U.s., Llc
Charlotte, NC, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Covidien
TIJUANA, B.C. Mexico, MX
Merit Medical Canada Ltd.
Markham Ontario, CA
Carefusion D.r. 203 Ltd.
SANTO DOMINGO Distrito Nacional, DO
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.