FDA Device Intelligence
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System, Irrigation, Urological

FDA product code LJH · Class 2 · Gastroenterology, Urology

41
Registered devices
1,124
Adverse events
7
Recalls
29
510(k) clearances

Devices with this code

MEDLINE — MEDLINE INDUSTRIES, INC.Irrigation Set — B. BRAUN MEDICAL INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONIrrigation Set — B. BRAUN MEDICAL INC.Arthromatic/Uromatic — BAXTER INTERNATIONAL INC.MONARCH™Platform, Urology — Auris Health, Inc.Arthromatic/Uromatic — BAXTER INTERNATIONAL INC.Irrigation Set — B. BRAUN MEDICAL INC.Arthromatic/Uromatic — BAXTER INTERNATIONAL INC.Irrigation Set — B. BRAUN MEDICAL INC.MED-RX — Canadian Hospital Specialties LimitedMedline — MEDLINE INDUSTRIES, INC.Irrigation Set — B. BRAUN MEDICAL INC.EQUIMAT — Karl Storz GmbH & Co. KGNA — BAXTER INTERNATIONAL INC.Irrigation Set — B. BRAUN MEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.Asurys™ — BOSTON SCIENTIFIC CORPORATIONArthromatic/Uromatic — BAXTER INTERNATIONAL INC.Irrigation Set — B. BRAUN MEDICAL INC.Asurys™ — BOSTON SCIENTIFIC CORPORATIONAMSure® Four Lead Bladder Irrigation Set — AMSINO INTERNATIONAL, INC.NA — BAXTER INTERNATIONAL INC.Medline — MEDLINE INDUSTRIES, INC.

Recent recalls

DateFirmReason
2022-08-19Canadian Hospital SpecialtiesSome of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
2014-06-20Stryker EndoscopyInternal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the pro
2014-03-25Hospira Inc.The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No
2014-03-25Hospira Inc.The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No
2013-05-15Baxter Healthcare Corp.A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user pr
2013-05-15Baxter Healthcare Corp.A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user pr
2013-05-15Baxter Healthcare Corp.A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user pr

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.