The Recall Desk

FDA (Devices) recall action 91087

Cardinal Health recalled 6 products on 2022-12-14

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2022-12-14
Critical
0
Units

Why these products were recalled

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • HighFDA (Devices)··2022-12-14

    Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-12-14

    Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk

    Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-12-14

    Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-12-14

    Dover urinary catheter drainage bag occlusion defect nationwide recall

    Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-12-14

    Dover Urinary Catheter Drainage Bag Port Occlusion Recall

    Cardinal Health is recalling Dover closed urethral catheter trays due to potential occlusion of the drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-12-14

    Dover Urethral Catheter Drainage System Recall for Potential Port Blockage

    Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
    Category
    Distribution
    0 states