Home › Device types › LJH
System, Irrigation, Urological
FDA product code LJH · Class 2 · Gastroenterology, Urology
39
Registered devices
1,103
Adverse events
7
Recalls
28
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONIrrigation Set — B. BRAUN MEDICAL INC.MED-RX — Canadian Hospital Specialties LimitedIrrigation Set — B. BRAUN MEDICAL INC.NA — BAXTER INTERNATIONAL INC.MED-RX — Canadian Hospital Specialties LimitedIrrigation Set — B. BRAUN MEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.Irrigation Set — B. BRAUN MEDICAL INC.Irrigation Set — B. BRAUN MEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.NA — BAXTER INTERNATIONAL INC.NA — BAXTER INTERNATIONAL INC.Irrigation Set — B. BRAUN MEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.n.a. — Karl Storz GmbH & Co. KGAMSure ® Cystoscopy/Bladder Irrigation Set — AMSINO INTERNATIONAL, INC.NA — BAXTER INTERNATIONAL INC.NA — BAXTER INTERNATIONAL INC.MED-RX — Canadian Hospital Specialties LimitedAsurys™ — BOSTON SCIENTIFIC CORPORATIONMedline — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-19 | Canadian Hospital Specialties | Some 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. |
| 2014-06-20 | Stryker Endoscopy | Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the pro |
| 2014-03-25 | Hospira 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 |
| 2014-03-25 | Hospira 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 |
| 2013-05-15 | Baxter 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 |
| 2013-05-15 | Baxter 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 |
| 2013-05-15 | Baxter 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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