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MED-RX
Canadian Hospital Specialties Limited · Model 10-4001 · UDI-DI 00628725001050
LJH
Prescription
10
510(k) clearances
1,103
Adverse events (2 deaths)
7
Recalls
72
Facilities
Description
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET
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 product. |
| 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. 04693-01, Latex Fr |
| 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. 04693-01, Latex Fr |
| 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 prior to use and could |
| 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 prior to use and could |
| 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 prior to use and could |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.