Lavage, Jet
FDA adverse event reports and recall history for lavage, jet (product code FQH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,834
- Deaths
- 5
- Injuries
- 327
- Malfunctions
- 4,477
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-05-10Open, ClassifiedProcess control
Medtronic Clearview Blower/Mister, Model Number 22120
Potential for unsealed sterile packing.
- 2022-09-26Open, ClassifiedEnvironmental control
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.
- 2015-07-24TerminatedOther
Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
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.
- 2015-07-13TerminatedPackage design/selection
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-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
Potential sterility breach in the packaging.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
- 2011-01-25TerminatedPackaging process control
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
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.
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