Apparatus, Suction, Patient Care
Cardiovascular · 21 CFR 870.5050
Recent MDR events
1,122 adverse event reports on file
- PLEURX DRAINAGE KIT 1000MLJul 20, 2026MalfunctionCarefusion, Inc1423507-2026-00106
- PLEURX DRAINAGE KIT 1000MLJul 20, 2026MalfunctionCarefusion, Inc1423507-2026-00105
- PLEURX DRAINAGE KIT 500ML 10/CSJun 30, 2026MalfunctionCarefusion, Inc1423507-2026-00095
- PLEURX PLEURAL CATHETER MINI KITJun 27, 2026MalfunctionCarefusion, Inc1423507-2026-00093
- PLEURX PLEURAL CATHETER KITJun 24, 2026MalfunctionCarefusion, Inc1423507-2026-00092
- UNKNOWN PRODUCT PLATFORMJun 18, 2026MalfunctionCarefusion, Inc1423507-2026-00088
- PLEURX PLEURAL CATHETER MINI KITJun 18, 2026MalfunctionCarefusion, Inc1423507-2026-00084
- PLEURX PLEURAL CATHETER MINI KITJun 12, 2026MalfunctionCarefusion, Inc1423507-2026-00083
- PLEURX PLEURAL CATHETER MINI KITMay 29, 2026MalfunctionCarefusion, Inc1423507-2026-00076
- PLEURX PLEURAL CATHETER AND STARTER KITMay 27, 2026MalfunctionCarefusion, Inc1423507-2026-00075
Event type breakdown
Recalls
3 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Ster
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1599-2022 · View FDA record ↗ - Pfm Medical IncTerminatedDec 12, 2014
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Z-0561-2015 · View FDA record ↗ - Pfm Medical IncTerminatedDec 12, 2014
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Z-0562-2015 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Carefusion 2200, Inc.
Vernon Hills, IL, US
Carefusion D.r. 203 Ltd.
SANTO DOMINGO Distrito Nacional, DO
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
C.r. Bard, Inc.
MADISON, GA, US
Merit Medical Uk Limited
Earley Reading, GB
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Isomedix Operations, Inc.
Temecula, CA, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Merit Medical Systems, Inc.
South Jordan, UT, US
Merit Medical Canada Ltd.
Markham Ontario, CA
Sterigenics U.s., Llc
Salt Lake City, UT, US
C.r. Bard, Inc.
COVINGTON, GA, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Bearpac Medical, Llc
Moultonborough, NH, US
510(k) clearances
19 clearances for this product code
- Merit Medical Systems, Inc.Mar 3, 2023
K212696 · Aspira Pleural Drainage System
- Rocket Medical PlcSep 9, 2021
K210509 · Rocket Platinum Cured Cathter
- Bearpac MedicalNov 20, 2020
K201404 · Passio Pump Drainage System
- Bearpac MedicalJul 25, 2019
K190292 · Passio Pump Drainage System
- Rocket Medical PlcAug 17, 2017
K163321 · Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
- Care FusionOct 31, 2016
K160450 · Pleurx Pleural Catheter System
- Care FusionJul 2, 2015
K141965 · PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
- Rocket Medical PlcFeb 1, 2013
K123033 · ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B