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
Reported: December 14, 2022 Initiated: November 1, 2022 #Z-0360-2023
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Cardinal Health
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health. Units affected: N/A.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2022. Severity: Moderate. Recall number: Z-0360-2023.
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