Lavage, Jet
General Hospital · 21 CFR 880.5475
Recent MDR events
4,888 adverse event reports on file
- Fan Spray KitJul 31, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00899
- Fan Spray KitJul 30, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00915
- HIP KITJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00907
- HIP KITJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00909
- FAN SPRAY KITJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00911
- HIP KITJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00912
- FAN SPRAY KITJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00913
- FAN SPRAY KITJul 28, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00901
- HIP KITJul 28, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00902
- SHOWER SPRAY KITJul 28, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00903
Event type breakdown
Recalls
29 recall events for this product code
- Medtronic Perfusion SystemsOpen, ClassifiedMay 10, 2024
Medtronic Clearview Blower/Mister, Model Number 22120
Potential for unsealed sterile packing.
Z-1794-2024 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedSep 26, 2022
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Z-1787-2022 · View FDA record ↗ - EXP Pharmaceutical Services CorpTerminatedJul 24, 2015
Medical Device Exchange FEMORAL CANAL TIP;
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Z-2231-2015 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedJul 13, 2015
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Wo
Potential sterility breach in the packaging.
Z-2062-2015 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0947-2011 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0948-2011 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0949-2011 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0950-2011 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0951-2011 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJan 25, 2011
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tu
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Z-0952-2011 · View FDA record ↗
Registered firms
195 firms currently registered for this product code
Guangzhou Clean Medical Products Manufacturing Corp
Guangzhou Guangdong, CN
Microport Orthopedics Inc.
Arlington, TN, US
Kdl Medical, Inc.
RICHARDSON, TX, US
Erbe Elektromedizin Gmbh
Rangendingen Baden-Wurttemberg, DE
Smith & Nephew, Inc.
Lawrenceville, GA, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Premier Brands Of America Inc.
Hudson, NY, US
Boston Scientific Corporation
Coventry, RI, US
Irrimax Corporation
Lawrenceville, GA, US
Elite Medtek(jiangsu) Co., Ltd
Changzhou City Jiangsu, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
De Soutter Medical Ltd.
ASTON CLINTON Buckinghamshire, GB
Sterigenics Us Llc
Gurnee, IL, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Amerx Healthcare Corp
Oldsmar, FL, US
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Beijing Yuewei Medical Technology Co., Ltd
Beijing, CN
Erbe Elektromedizin Gmbh
TUEBINGEN Baden-Wurttemberg, DE
Medtronic Perfusion Systems
Minneapolis, MN, US
Isomedix Operations Inc
GROVEPORT, OH, US
Dongguan Kaiser Technology Co., Ltd
Dongguan city Guangdong, CN
510(k) clearances
53 clearances for this product code
- Becton, Dickinson and Company (BD)Feb 25, 2026
K253996 · BD Surgiphor Antimicrobial Irrigation System (910110)
- BdFeb 20, 2026
K253445 · BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- Erbe Elektromedizin GmbHJun 15, 2023
K231023 · ERBEJET® 2 System
- Armis Biopharma, Inc.May 25, 2023
K220759 · Armis VeriCyn Wound Wash
- Smith & Nephew Medical LimitedMay 16, 2023
K220964 · VERSAJET Hydrosurgery System (III)
- BdOct 14, 2022
K221504 · BD Surgiphor Antimicrobial Irrigation System
- Irrimax CorporationSep 22, 2022
K222804 · Irrisept Antimicrobial Wound Lavage
- Inopro, Inc.May 31, 2022
K210987 · IRRIGO Wound Wash Jet System