Home › Device types › FQH
Lavage, Jet
FDA product code FQH · Class 2 · General Hospital
660
Registered devices
4,888
Adverse events
29
Recalls
53
510(k) clearances
Devices with this code
CLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.Well at Walgreens — WALGREEN CO.palaJet ® — Guangzhou Clean Medical Products Manufacturing Corp.CLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.De Soutter Medical — DE SOUTTER MEDICAL LIMITEDCarboJet® CO2 Bone Lavage System — Kinamed, Inc.MicroAire® — Microaire Surgical Instruments LLCitool® ApexPulse™ — Apex (Guangzhou) Tools & Orthopedics Co.PULSAVAC® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.De Soutter Medical — DE SOUTTER MEDICAL LIMITEDCARDINAL HEALTH — Cardinal Health 200, LLCKroger Saline Wound Wash — KROGER CO., THECarboJet® CO2 Bone Lavage System — Kinamed, Inc.PULSAVAC® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.CarboJet® CO2 Bone Lavage System — Kinamed, Inc.MicroAire® — Microaire Surgical Instruments LLCElefant — Coloplast A/SITOOL — Apex (Guangzhou) Tools & Orthopedics Co.CLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.MicroAire® — Microaire Surgical Instruments LLCPULSAVAC® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.InterPulse — STRYKER CORPORATIONH-Chlor® Solution — PATRIN PHARMA, INC.DG Health — DOLGENCORP, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-19 | Medtronic Perfusion Systems | Potential for unsealed sterile packing. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2019-08-16 | IrriMAX Corporation | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |
| 2019-01-24 | Maquet Cardiovascular, LLC | Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2015-05-08 | Stryker Instruments Div. of Stryker Corporation | Potential sterility breach in the packaging. |
| 2015-02-11 | EXP Pharmaceutical Services Corp | 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 |
| 2010-10-04 | Stryker Instruments Division of Stryker Corporation | 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 p |
| 2010-10-04 | Stryker Instruments Division of Stryker Corporation | 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 p |
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