Catheter, Peritoneal
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
124 adverse event reports on file
- CORE DYNAMICSMay 1, 2026InjuryConmed3007305485-2026-00107
- CATHETER, PERITONEALApr 22, 2026InjuryUnknownMW5187209
- CATHETER, PERITONEALApr 21, 2026InjuryUnknownMW5187095
- CATHETER, PERITONEALApr 21, 2026InjuryUnknownMW5187101
- CONMED CORE SUCTION IRRIGATORApr 1, 2026OtherConmed CorporationMW5186258
- CORE REPOSAL TRUMPETJan 13, 2026MalfunctionConmed CorporationMW5182113
- ARROW PERITONEAL LAVAGE CATH KIT:8FROct 19, 2023InjuryArrow International Llc9680794-2023-00787
- ARROW PERITONEAL LAVAGE CATH KIT:8FROct 19, 2023InjuryArrow International Llc9680794-2023-00788
- PD CATHETERAug 12, 2023MalfunctionUnknownMW5130193
- PD CATHETERAug 12, 2023InjuryUnknownMW5131797
Event type breakdown
Recalls
15 recall events for this product code
- ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2380-2026 · View FDA record ↗ - Teleflex MedicalTerminatedAug 10, 2012
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC.
Product is missing the label on the internal packaging.
Z-2186-2012 · View FDA record ↗ - Boston Scientific CorporationTerminatedMay 21, 2009
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
Z-1334-2009 · View FDA record ↗ - Taut, Inc.TerminatedFeb 15, 2007
Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; T
Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
Z-0428-2007 · View FDA record ↗ - Boston Scientific CorpTerminatedSep 13, 2006
Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010
Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
Z-1499-06 · View FDA record ↗ - Arrow International IncTerminatedAug 25, 2004
Peritoneal Lavage Kits, Model number AK-09000
wrong introducer needle in some kits
Z-1408-04 · View FDA record ↗ - Arrow International IncTerminatedAug 25, 2004
Peritoneal Lavage Kits, Model number AK-09001
wrong introducer needle in some kits
Z-1409-04 · View FDA record ↗ - ConMed CorporationTerminatedUnknown
CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Z-0129-2017 · View FDA record ↗ - ConMed CorporationTerminatedUnknown
CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Z-0130-2017 · View FDA record ↗ - ConMed CorporationTerminatedUnknown
CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Z-0132-2017 · View FDA record ↗
Registered firms
59 firms currently registered for this product code
Guatemala Medical Manufacturing
Villa Canales Guatemala, GT
Fortune Medical Instrument Corp.
Taoyuan City, TW
Sterigenics U.s., Llc
Salt Lake City, UT, US
Teleflex Medical Llc
Morrisville, NC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Boston Scientific Corporation
Saint Paul, MN, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Rece International Corp.
Miami, FL, US
Lsl Healthcare
Niles, IL, US
Merit Medical Canada Ltd.
Markham Ontario, CA
Teleflex Llc (nadc)
Olive Branch, MS, US
Medline Chile Spa
Pudahuel Region Metropolitana, CL
Medionics International, Inc.
MARKHAM Ontario, CA
Cook Incorporated
Bloomington, IN, US
Cook Incorporated
Spencer, IN, US
Deroyal Industries, Inc.
POWELL, TN, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Conmed Corporation
Greenwood Village, CO, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Ameco Medical Industries
10TH OF RAMADAN CITY Ash Sharqiyah, EG
510(k) clearances
17 clearances for this product code
- Taut, Inc.Oct 5, 1999
K992904 · MINI-PORT
- Taut, Inc.Oct 5, 1999
K992907 · INTRADUCER
- Taut, Inc.Dec 1, 1997
K972112 · INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
- Sil-Med Corp.Aug 8, 1996
K961194 · ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
- Medical Components, Inc.Mar 21, 1996
K960426 · MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
- Sil-Med Corp.Jan 4, 1996
K942709 · MEDIASTINAL SILICONE DRAINS
- Sherwood Medical Co.Feb 24, 1994
K933510 · ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
- Core Dynamics, Inc.Nov 12, 1993
K926477 · BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO